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İlaç araştırmalarında şeffaflık ne durumda?
BMJ Open'da yayınlanan bir çalışma FDA tarafından 2012'de onaylanan 15 ilacı klinik araştırma şeffaflığı açısından incelemiş. İlaçların yarısında açıklanmamış en az bir Faz II veya III çalışma varken, yasal olarak çalışmları topluma açıklanması gereken ilaçların yalnız %67'si bunu yapmış.


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EMA to Allow Biosimilar Applications to Reference Data from Products Approved Outside EU..
The European Medicines Agency (EMA) has updated its guidance for pharmaceutical companies on biosimilar medicines to clear that it intends to accept batches of reference medicines sourced from outside the European Economic Area in the future. 


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Happy New Year..
Merry Christmas and a Happy New Year from Turkish Association of Clinical Research..




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FDA and EMA agrees on inspections of bioequivalence studies..


The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals.


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Celebrating the International Women's Day..

Turkish Clinical Research Association is celebrating the International Women's Day for the economic, political and social achievements of women past, present and future.

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Merry Christmas..


Clinical Research Association wishes a happy new year and merry Xmas to all our friends.. 


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MoH announcement about audits to CROs in Turkey

According to the recent  announcement from Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals through their web site the Contract Research Organizations have to be audited by  Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals in order to conduct clinical research activities in Turkey.



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MoH- E-applications to Clinical Research Department started

According to the announcement from Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals through their web site ; starting from April 15th, 2010 all applications should be made both by paper format and electronic format. All documents in the applications dossier will be uploaded to IEGM2007 system by Ministry of Health (MoH) General Directorate of Pharmaceuticals.

 



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Danish case handling times for clinical trials in 2010

Danish Medicines Agency must handle applications for authorisation of clinical trials within 30 working days. The chart shows the case handling times for applications received by the Danish Medicines Agency during each month of 2010.

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The new regulation that revised the Clinical Trials Regulation (2009) can be reached from our webpages...

The new regulation that revised the Clinical Trials Regulation (2009) can be reached from our webpages.

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EMEA is establishing a project is for candidate countries..

The aim of the project is to build contacts and relationships between the EMEA and the Candidate and Potential Candidate Countries, for future collaboration in the EMEA’s activities and its relationships with Member States.

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Thalidomide apology from England after 50 years..
 
Mr O'Brien, the MP for North Warwickshire said that ¨The Government wishes to express its sincere regret and deep sympathy for the injury and suffering endured by all those affected when expectant mothers took the drug thalidomide between 1958 and 1961.¨ About 2,000 babies were born with deformities as a result of the drug.

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UK response to European Commission review of the Clinical Trials Directive..
The views of MHRA have now been incorporated into the UK’s overall response to the EU's revision process of Clinical Trials Directive 2001/20/EC, and published on the website.

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CTM December: Medical Publication Trends by Geographic Region..

In the December issue of CTM, medical publications were analysed depending on Index Medicus (PubMed) database. There is a considerable increase in the number of publications from Asia and Emerging countries. Performance of Turkey is outstanding in both total number of publications, number of articles published in high ranked journals and number of evidence based articles. Go to the news to reach the full-text article.

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New web addresses..
You can now reach our webpages from these addresses: www.cresearchtr.org or www.researchtr.org Please bookmark.



Last issues of CTM..

The 10-11th issues of CTM are devoted to the CTM congress.

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Merry christmas and a happy new year..
Clinical Research Association wishes a merry christmas and a happy new year...


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International Compilation of Human Research Protections..
The International Compilation of Human Research Protections is the standard reference for researchers, regulators, and IRBs/ethics committee members involved in human subjects research around the world.
The Compilation lists the laws, regulations, and guidelines for human subjects research in 94 countries, and from a number of international and regional organizations. The standards are organized into 6 categories:
General
Drugs
Privacy/Data Protection
Human Biological Materials
Genetic
Embryos, Stem Cells, and Cloning

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EORTC course on statistics for non-statisticians..

EORTC is helding the next EORTC course "Clinical Trial Statistics for Non Statisticians", in Brussels, Belgium, on 15-18 June 2010.


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"Towards A Better Future for Pharmacovigilance in Clinical Trials” by EORTC and ECRIN..

EORTC and ECRIN is organizing a Multidisciplinary Workshop on "Towards A Better Future for Pharmacovigilance in Clinical Trials” on behalf of the Road Map Initiative for Clinical Research in Europe.

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FDA Issues Final Guidance on Investigator Responsibilities

FDA has issued final guidance on "Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects." 

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Drug ads are troubling search engines..

Major USA search engines are pressed to stop advertisings from overseas.

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CTM new issue..

The August issue deals with Oncology trials. Oncology accounts for 20.8% of all industry sponsored trials and 20.9% of all sites. Non-industry sponsored oncology trials account for 40.1%. Another manuscript shows that there are 4 Ethical Committes in Turkey approved by USA Office of Human Research Protections.


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FDA Expands Access to Investigational Drugs..

FDA has had rules in 1987 that have allowed  patients to have access to investigational drugs. On August 12, 2009, FDA announced changes to the rules to make them broader and clearer for the patient and the treating physician.




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The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities..

The initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency and the US FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections.
This initiative is an important contribution to ensuring the protection of clinical-trial subjects in the context of the increasing globalisation of clinical research. The European Medicines Agency and the FDA will start their new initiative with an 18-month pilot phase on 1 September 2009.

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MoH approved the Central Clinical Trials Advisory Board and new Ethical Committees...
After the new GCP regulation, the MoH approved the Central Clinical Trials Advisory Board and 7 Clinical Research Ethical Committees.

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Researchers demand more harmonization of European rules for approving clinical studies (from Nature)..

Despite efforts to harmonize the way European countries approve clinical trials, a researcher may see their proposed study rejected in one nation but approved in another. The article in Nature underlines this topic.

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New issue of Clinical Trial Magnifier..

This Issue contains "Industry Trials in BRIC Countries - Brasil, Russia, India and China".

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Clinical trials in Turkiye..

The analysis of clinical tirals conducted in Turkey according to clinicaltrials.gov is updated..

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USA priorities in Comparative-Effectiveness Research
Directed by Congress to develop a list of priorities for the Department of Health and Human Services (DHHS) ended up in a list of priorities of comparative-effectiveness research (CER).

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New documents are on our webpage..
Guidance On The Application Format And Documentation To Be Submitted In An Application For An Ethics Committee Opinion On a Clinical Trial
Manufacture Of Investigational Product(s)
Agreement For Transfer Of Biological Material To Be Used In Clinical Researches
Clinical Trial Budget Form
Ethics Committee Evaluation Form Of A Clinical Trial Application
Standard Operating Procedure Of Ethics Committees
Guidance On Insuring Subjects In A Clinical Trial
Guidance On Observational Studies Performed With Drugs
Guideline On The Compassionate Use Program 01.02.2009
Application Form To Import Investigational Products For Clinical Trial Use
Guideline For Good Clinical Practices -2009
Clinical Trial Application Form
Guidance On The Collection, Verification And Presentation Of Adverse Reaction Reports Occurring During Clinical Trials
Annual Notification Form To The Ministry And Ethics Committee For A Clinical Trial
Notification Form Of The End Of A Clinical Trial To The Ministry And The Ethics Committee
Headings For Aspects Of A Clinical Trial That Might Require A Substantial Amendment
Notification Form To Obtain Ministry Approval and Opinion of The Ethics Committee For a Substantial Amendment To a Clinical Trial
Application Form Of A Clinical Trial For Specialty Thesis and/or Academic Purposes


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ICREL (Impact on Clinical Research of European Legislation) report has been submitted to the European Commission...

ICREL was a one-year project financed by the European 7th Framework Programme. Under EFGCP’s coordination, ECRIN, EORTC, as well as the Hospital Clínic of Barcelona and the Ethics Committee of the Medical University of Vienna collaborated in this project.

Its aim was to measure and analyse the direct and indirect impact of the Clinical Trials Directive2001/20/EC and related legislations in the EU on all categories of clinical research.

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Clinical Research Discussion Forum..

You can start using the Clinical Research Discussion forum from our webpage...

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CTM 2009 Congress..

Clinical Trial Magnifier 2009 Congress will be held in Hong Kong on November 13-15, 2009.

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Scientific fraud disclosed..
A leading anesthesiology researcher has been accused of falsifying data and other fraud in potentially dozens of published studies.

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FDA inspections from the last issue of Clinical Trials Magnifier..
The title of the manuscript is "US FDA Site Inspection Findings, 1997-2008, Fail to Justify Globalization Concerns"

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MoH initiated the accreditation of CRO's..
After the new GCP regulation came into effect, Ministry of Health begin accreditation of CRO's. MENE RESEARCH is the first CRO who gets an accreditation.

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A survey on investigator-initiated studies
A survey on investigator-initiated studies is being conducted by Clinical Trials Magnifier Journal. To respond to the survey, please go to the news.

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New ethical committees..
The cities where the new ethical committees will be organized according to the new GCP regulation is listed.

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New issue of Clinical Trial Magnifier..
This issue includes articles on Validity of Clinical Trials in emerging countries, a survey on Phase I trials and US FDA New Drug Approval Trends, 1999-2008.


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FDA warned against Ranbaxy laboratories..
FDA reported that India based Ranbaxy laboratories has provided falsified data for the approval of drugs.


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Updated web site of General Directory of Pharmacy and Pharmaceuticals is online..

The new interface deserves attention for the functional design and easy access to documents. The English version will  be available soon.


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Turkish Clinical Research Organization Association..

Turkish Clinical Research Organization Association is founded in January. The Society aims to collobrate between its members, represent them in various platforms, and improve the efficiency and quality in Clinical Research. Education is also a main priority of the organization.


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FDA issued a warning for Metoclopramide..

A commonly used drug, metoclopramide requires a box warning for tardive dyskinesa.


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FDA approvals won't save companies..

The US Supreme Court ruled that drug makers can be held liable for harm caused by their medicines, even if the drugs already carry federally approved warning labels.


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2nd annual World Rare Disease Day and Orphan Drugs..

Organizations around the world are observing February 28, 2009, as the 2nd annual World Rare Disease Day—an important time for bringing attention to the needs of people with rare diseases. The term "orphan drug" refers to a drug or biologic (such as a vaccine or blood product) that treats a rare disease or condition. The ODA defines a disease as rare if fewer than 200,000 people in the United States have it.


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Guideline for Pharmacovigilance inspections (English version)
Guideline for Pharmacovigilance inspections in English can be reached from our web pages.

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Two new guidelines..
English versions of "Guideline for Good Clinical Practices" and "Guidance on the collection, verification and presentation of adverse reaction reports occuring during clinical trials" can be reached from our web pages.

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A new guideline..
"Guideline regarding application format and documentation to be submitted to in an application for ethics committee opinion in clinical trials" can be reached from our webpage.

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Pfizer is disclosing Payments to U.S. Doctors..

Pfizer Inc., will make public its payments to U.S. doctors for consulting, speeches and research.

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Thaildomide, a drug developed by Nazis?
According to Daily Mail newspaper, Nazis developed Thalidomide and tested it on prisoners.

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30 years post Belmont..

The most important document on clinical trials in USA "Belmont Report" was published on 18 April 1979.

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GCP Guideline is published..

The GCP Regulation published in January 2009, is followed with the new GCP Guideline today..

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NIH launches a web site on medical research involving children..

The new website offers parents and healthcare providers a guide to to children's medical research.

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First NHS Constitution launched..
The first 10-year Constitution for the NHS has been unveiled by the UK Prime Minister. The constitution includes a right to makes choices about your care and to information to help exercise that choice; a right making explicit your entitlement to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you; a right to expect local decisions on funding of other drugs and treatments to be made rationally following a proper consideration of the evidence.

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Last update of clinicaltrials.gov analysis of Turkiye..

The last update of clinical trials in Turkiye in clinicaltrials.gov can be reached from here.

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Guideline on Compassionate Use Program (2009)
The English version of the Guideline on Compassionate Use Program effective in January 2009 is on our webpage.

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Sponsored clinical trials in Endocrinology and Respiratory diseases..

Clinical Trial Magnifier published the analysis of Sponsored clinical trials in Endocrinology and Respiratory diseases. Respiratory disease phase I-IV trials account for 11.2% of all industry sponsored trials registered with ClinicalTrials.gov. Leading respiratory diseases under clinical trial are asthma, lung cancer and influenza/flu. The analysis found 837 trials with 18,160 study sites and 294,507 study subjects for endocrine disease phase I-IV trials on drugs and biologics in the US trial register. Diabetes/Glucose accounting for 55.6% of the endocrine phase II-IV trials, Cholesterol/Lipids 15.2%, Osteoporosis/Bone Metabolism 8.9% and Obesity/Body Weight 7.2%.
 

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FDA alerted consumers not to buy or use more than 25 different weight-loss pill products..

Food and Drug Administration (FDA) alerted consumers not to buy or use more than 25 different weight-loss pill products because the products may be harmful to their health.

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Happy New Year..

Clinical Research Society wishes a happy new year and a peaceful world in 2009.

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Revision to Guidance on Observational Studies Performed with Drugs...
The Guidance on Observational Studies Performed with Drugs is revised.

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Orphan Drugs in Europe..

EMEA published a report on orphan drugs approved in Europe (defined as those that affect fewer than five in 10,000 persons in the European Union).

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New GCP regulation..
The English version of the new GCP regulation effective on 23 December 2008 can be reached from our webpage..

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New Regulation on GCP is active now..
The new GCP regulation is published today in the Official Gazette.

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First Phase I study in Turkey..
Te completion of first Phase I clinical trial done by sanofi aventis in Turkey was celebrated on 15 December 2008.

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Patient recruitment in EORTC...

Turkey recruited 590 patients in EORTC studies between 2000-2007. A total of 42.098 patients were recruited during this period.
Turkey is the second most recruiting non-EU country in Europe.

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A web site for GCP Regulations in UK..

Clinical Trials Toolkit web site is for help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.

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International Compilation of Human Subject Protections-2009

The 2009 edition of the International Compilation of Human Subject Protections has just been released and is now available on-line.

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Analysis of clinical trials in Turkiye..


The analysis of clinical trials in Turkiye registered to Clinicaltrials.gov web site is updated on 07 September 2008..



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Update on Turkiye in Clinicaltrials.gov..


The analysis of clinical trials in Turkiye registered to Clinicaltrials.gov web site is updated on 07 September 2008..



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Guideline for Compassionate Drug Use Program...
The English version of Guideline for Compassionate Drug Use Program can be reached from our web pages.

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Investigator Initiated Trials..

Clinical Trial Magnifier published a review on Investigator Initiated Trials. An analysis on registered to ClinicalTrials.gov showed that in the last 3 years a total of 24,931 new Phase I-IV study was registered and 13,065 (52.4%) of these studies were non-industry sponsored. 23% of these were Oncology studies.

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Helsinki Declaration - Seoul 2008..

The last version of "Ethical Principles for Medical Research Involving Human Subjects", also known as Helsinki Declaration is on the web.

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JAMA Manuscript: Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union..

After the approval of first biological in October 1982, more than 250 biologicals was approved in USA and EU. The article published in JAMA is on the Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union.

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Sponsored Clinical Trials in Korea and China..

The new issue of Clinical Trials Magnifier on-line journal is on "Sponsored Clinical trials in Korea". The previous issue was on sponsored clinical trials in China.

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New Regulation on GCP in Turkey..

The new regulation on GCP in Turkey is signed by the MoH and sent to Prime Minister for approval.

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FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals..

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs.

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The European Commission has published two guidelines concerning orphan medicinal products...

The guidelines are about the application of Articles 8(1), (2) and (3) of Regulation (EC) No 141/2000 on orphan medicinal products:
- the possibility for Member States to inform the European Medicines Agency that the criteria on which market exclusivity was granted may no longer be met (potentially resulting in the market exclusivity period for the medicine concerned being shortened); and
- assessment of the similarity of medicinal products, which is a requirement for accepting marketing authorisations when orphan medicinal products have been authorised for similar indications.

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Industry Sponsored Clinical Trials in China..
The August issue of Clinical Trial Magnifier is on "Industry Sponsored Clinical Trials in China".

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Submitting for clinical trials with medical devices in Turkey..
You can find some questions and answers detailing this subject, on our webpages.

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FDA Issued an alert for Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India

The Food and Drug Administration (FDA) issued two Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. FDA also issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

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New documents on our webpage..


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Characteristics of True Global Sponsored Clinical Trials

The analysis was reported in ClinicalTrials.gov and comprised 5,167 trials and 126,980 study sites registered between October 2005 and September 2007.

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New documents on our webpage..
Draft guidance on specific modalities for non-commercial clinical trials - 2006.

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After the illegal Botox..

The hunt by FDA that started in 2004 after the illegal botox; which caused paralysis of 4 patients due to cosmetic use, led to interesting findings.

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New links on our webpage..
A new document is added to our webpage on "Information And Documents To Be Included In The Application File To Be Prepared For The Import Of Drugs To Be Used In Clinical Drug Trials and Information And Documents To Be Included In The Application File To Be Prepared For The Control Of The Centers Performing Bioavailability And Bioequivalence Studies"

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Researcher got paid for accidental infection

New Zealand's department of labour has admitted that a researcher who lost her legs and arms due to meningococcal septicaemia in 2005, probably became infected while working at a government laboratory.

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Regulation Regarding the Implementation and Inspection of the Support for Research & Development Activities
Ministry of Industry and Trade released the Regulation Regarding the Implementation and Inspection of the Support for Research & Development Activities. This Regulation shall encompass the procedures and principles on the implementations and inspections of the support and incentives for technology centers (technology center operations), on the Establishment of the Small and Medium Industry Development Directorate as well as the R&D centers, R&D and innovation projects, pre-competition cooperation projects and techno-venture capital.

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FDA issued a final regulation that makes early Phase I clinical drug development safe and efficient

FDA issued a final regulation that makes early Phase I clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes.

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New links on our webpage..

A new link is added to our webpage that gives information about the web addresses of international and national authorities regulating clinical trials.

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Industry clinical testing of new medicinal products requires 95,000 study sites and 1,300,000 subjects..

The annual investment for this research is estimated to be US$38.5 billion; US$9.6 billion for internal costs, US$8.5 billion to investigators and US$19.3 billion to clinical trial service providers.

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Epilepsy drug Topamax is related to birth defects.

English researchers showed that the use of Topamax in 203 pregnant woman who gave birth to 178 children, caused 16 babies with birth defects.

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Harmonisation of GCP inspection in member states of EU..

I
n order to harmonise the conduct of Good Clinical Practice (GCP) inspections by the competent authorities of the Member States, guidance documents containing the common provisions on the conduct of those inspections are now published in Chapter IV of the Eudralex - Clinical Trials Volume 10.
 


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New additions to our web pages..
Starting today, you will receive an e-mail everytime there is a new addition to our web pages.

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Summer School on Molecular Modeling and Drug Design..
"Summer School on Molecular Modeling and Drug Design" 2008 meeting will be held in Istanbul by Yeditepe University
between 10-14 September.


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FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety ..


In the first use of a framework allowing submission of a single application to the two agencies, the FDA and the EMEA worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs.



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Development of Sponsored Clinical trials in Asia

Engaged in 18.1% of all protocols globally Asia is involved in more sponsored trials than any other emerging region. You can read the details of this article published in the last issue of Clinical Trial Magnifier.

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UK's National Institute of Health and Clinical Excellence (NICE) will open its standing advisory committee meetings to public and press...
From June 2008 onwards the UK's National Institute of Health and Clinical Excellence (NICE) will open its standing advisory committee meetings to observers from the public and press.

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New Rule to Provide Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding..


The U.S. Food and Drug Administration proposed major revisions to the physician labeling for prescription drugs to provide better information about the effects of medicines used during pregnancy and breast-feeding.
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.



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ACRP 2009 Global Congress..

ACRP 2009 Global Congress will be held in Denver, USA between 24-28 April 2009. The ACRP 2009 Global Conference Program Planning Committee is issuing a call for proposals for oral and poster presentations for the 2009 Global Conference.



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Updated version of Guidance on Observational Studies Performed with Drugs in Turkey..
The first guideline was published on 22 Jan 2008. After some discussions, an updated version is issued.

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Stem cell studies accused of being unethical..

A civil court will hear the case of 70-year-old Dieter Bollmann, who paid more than €11,000 for a stem cell procedure to cure his urinary incontinence in 2005. He claims that doctors at the University Hospital Innsbruck told him that the treatment had a very high success rate, and implied that clinical trials had been completed. The consent form that Bollman signed does not include the word 'experimental'.

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Challenges and Barriers to Academic Cancer Research..
This is a presentation by EORTC Board member Tanja Cufer during the meeting titiled "The Burden of Cancer – How Can it be Reduced?" on February 7-8, 2008 in Brdo, Slovenia.

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2nd Workshop on Computer Aided Drug Design & Development: Molecular Modeling (WCADD-2)...

Computer Aided Drug Design and Development Society in Turkey ( CADD&D)" is helding the "2nd Workshop on Computer Aided Drug Design & Development: Molecular Modeling (WCADD-2)", on 26-29 June in Ankara, Turkey, which is hosted by Başkent University.

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Adverse drug reactions accounted for 3% of all deaths in Sweden..

According to this study 'Fatal Adverse Drug Reactions' (FADRs) is the seventh most common cause of death in Sweden.

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First National Congress of Pharmacovigilance
June 4-6, 2008
Antakya Hatay - Turkey

Schedule

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JAMA warns about ghost writing..

After it was learned that, most of the articles on the Merck & CO drug rofecoxib was written by for-profit companies and the academicians not necessarily involved in the research were presented as original writers, JAMA gave some clues to overcome the problem of ghost writing.

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2. Patient Safety Congress and Clinical Research Association..

The presentation by Şule Mene from Clinical Research Association in 2. Patient Safety Congress is on our web pages.

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A Guide to Drug Safety Terms by FDA..

FDA published a guide that offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug.

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Regulatory Authorities..
Comparative data on 10 Regulatory Authorities in Europe including Turkey can be reached from our web page.

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New law on R&D Support in Turkey..

New law issued on 28/2/2008 is published in Official Gazette.

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NEJM Editorial: Off-label drugs and FDA..

NEJM printed a paper on pros and cons of off-label drug use and the attitude of FDA in the recent years.

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FDA, initiated REMS for 25 drugs and biologic products..

FDA initiated the risk evaluation and mitigation strategy (REMS) under the Food and Drug Administration Amendments Act of 2007 (FDAAA) for 25 drugs. FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug.

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A report for EC on National Regulations of Ethics and Research in Turkey..

A report on "National Regulations on Ethics and Research in Turkey" prepared by Gülriz Uygur and Türkan Yalçin Sancar for European Commission can be reached from our web pages.

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English version of the guideline on...
English version of Guidance on Planning, Conducting and Evaluating Observational Studies Performed with Drugs in Turkey can be found on our web page.

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Drug usage trends in USA...

The results of an telephone survey sponsored by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health is published. According to the survey, half of the adults use at least one prescription drug daily, one-third have skipped filling a prescription because of cost and more than a half say they're at least "somewhat" confident medications are safe.


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Do you want to learn who is working where?..
To find the position and location please go to the main webpage. Under documents link you can find the "Who-Where?" section.

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FDA approved Nexium for chilkdren..

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD).

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Analysis of sponsored trials in the world..

"Sponsored Clinical Trial Globalization Trends" was published in Clinical Trial  Magnifier journal.

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FDA granted priority review for new indications of Peg-Interferon and Bortezomib..

The FDA has recently granted priority review status to two drugs -- Peg-Interferon for the treatment of melanoma, and Botezomib for the treatment of newly diagnosed multiple myeloma.

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Good Reprint Practices..

The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.



Pharmaceuticals and Healthcare 2008 Reports..
5 year industry forecast of 16 emerging european markets is published by Business Monitor.

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Celebrating the 25th year of Orphan Drug Act..
The term "orphan drug" refers to a drug or biologic, such as a vaccine or blood product, that treats a rare disease or condition. A disease is rare if fewer than 200,000 people in the United States have it. FDA is celebrating the 25th year of this succesfull act.

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Optimizing Clinical Trials in CEE & CIS Region conference..
The congress will be held in Vienna between 13-14 February. Sule Mene from the Turkish Clinical Research Association and Edibe Taylan from the pharmaceutical sector will be speakers. 

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FDA reported serious adverse events related to botox..

The reactions may be related to overdosing and there is no evidence that these reactions are related to any defect in the products. The most severe effects were found in spastic children treated with botox. This is not an FDA approved indication.

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FDA drug approvals declined 26 percent last year..

The FDA approved 69 new drugs in 2007 compared to 93 the year before according to Friedman, Billings, Ramsey analyst Jim Kumpel, CNN Money reports.

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West to East Drift in European Sponsored Clinical Trials..

Article titled " West to East Drift in European Sponsored Clinical Trials" can be reached from the Clinical Trial Magnifier newsletter.


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Reviewer leaked Avandia study..

According to a news in Nature, one of the reviewers of the metanalysis on the effect of Avandia (rosiglitazone)  published in New England Journal of Medicine, faxed a copy of the article to GlaxoSmithKline 17 days earier.

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How the world invests in R&D: from Nature..
The latest analysis from the US National Science Board (see Map) confirms that Israel leads the world in its economic devotion to research and development (R&D). Although US R&D investment was the world's largest — $340 billion — and in 2004, it was more than that of the rest of the G7 nations combined, the report offers some evidence of a slight decline in its standing.

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FDA warning on ENHANCE study..

The company stated that the ENHANCE study demonstrated no significant differences between Vytorin which contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet and Zocor on the build up of cholesterol plaque in the carotid (neck) arteries.  An IMPROVE IT trial is underway which is designed to evaluate the effect of Vytorin versus Zocor on heart disease and stroke. Until the FDA reviews the data, the agency advises patients to talk with their health care providers if they have questions about the ENHANCE study.

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Guideline on the planning, conduct and evaluation of observational studies in Turkey (In Turkish)
The 2008 Guideline on the planning, conduct and evaluation of observational studies in Turkey is finalized and activated.

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FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age

FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age.  FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.

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ISPOR Summer School: Pharmacoeconomics and Rational drug use

ISPOR is organizing a summer school in Antalya on Pharmacoeconomics and Rational drug use between 16-20 April. Click for details of the program.

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Turkey in clinicaltrials.gov

Clnicaltrials.gov is the biggest registry of clinical trials. We will publish the data from Turkiye sent to this site that will be updated quarterly. This data is derived by Nursah Omeroglu from Sanofi-aventis.

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Association of Research Based Pharmaceutical Companies has a new president..

Muhittin Bilgütay, General Director of Schering-Plough is the new president of AIFD (Association of Research Based Pharmaceutical Companies).

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PTI (Pharmaceutical Training International) 2008 Education Program..
PTI Education Program for year 2008 is finalized.

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Lady sentenced to 33 months after FDA investigation..

The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), commonly called “Lou Gehrig’s Disease.”

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No problems in Prilosec and Nexium..

FDA announced that the provided data did not favor an increased risk of cardiac events in patients using Prilosec or Nexium.

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The 2008 edition of the International Compilation of Human Subject Protections is now available..
The 2008 version lists about 900 laws, regulations, and guidelines from 84 countries on human subject protections, including four new countries: Georgia, Kazakhstan, Kuwait, and Turkey.

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Happy New Year..
Clinical Research Association wishes you a healthy and happy new year..

On Behalf of CRA President: Prof. Dr. Murat Akova
Web Coordinator: Prof. Dr. Hamdi Akan



The World Medical Association has initiated a request for comments on Helsinki Declaration..

Comments and suggestions were submitted this summer, collated and reviewed by the Working Group and the Medical Ethics Committee at their October 2007 meetings. The Working Group has prepared a set of suggested amendments to the Declaration

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Xenical is withdrawn from the market..

Ministry of Health warned that Xenical will be withdrawn from the market after an application by the manufacturer company - Roche..

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FDA reported a second warning on Fentanyl skin patch..

FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after people incorrectly used it.

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Adverse drug reactions in the elderly..


According to a study published in Annals of Internal Medicine drugs routinly used in elderly people have more serious side effects than the drugs accepted as having high risk.



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Presentations of the Audit & Inspections In Clinical Meeting
Presentations of the speakers participated in Audit & Inspections In Clinical Trials meeting can be found here..

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Problem with the smoking cessation drug?

FDA reported that suicidal ideation may develop in patients receiving Chantix (varenicline).

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Clinical Research Nurse

Ministry of Health is defining "Clinical Research Nurse" as a seperate identity. 

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Code of Ethical Promotion Practices for Medicinal Products..
Code of Ethical Promotion Practices for Medicinal Products issued by Association of Research-Based Pharmaceuticel Companies can be reached from our web pages.

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FDA issued a warning for commonly used flu drugs

FDA reported that neuropsychiatric side effects can be seen in individuals taking the influenza drugs oseltamivir (Tamiflu) and zanamivir (Relenza) ilke delirium, hallucinations and impulsive behavior.

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FDA issued a revision on labeling of Avandia (rosiglitazone)..


FDA concluded there is not enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. FDA is allowing Avandia to stay on the market while a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent, is conducted by GSK. The company agreed to add new information to the drug's labeling, warning of the potential for increased risk of heart attacks.



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MHRA recommends accreditation for Phase I trials..
After the TGN1412 incident, MHRA recommends accreditation for Phase I trials. For other news on this subject go to.. 

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Bayer suspends marketing of Trasylol..


Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.



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Glossary of Clinical Research..
A Glossary section is now available on the English Homepage..

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FDA alert on Exenatide

FDA issued on warning about the risk of acute pancreatitis in patients receiving an an antidibetic; Exenatide

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Updated draft of Turkish GCP..
The updated draft of the upcoming GCP can be reached from our webpage.

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Nature published an editorial on the accountability of the co-investigators in a research..

The editorial states that "there remains a need for a clearer understanding, both within a collaboration and by readers of the eventual papers, of the various contributions made by the authors not only to the research but also to safeguarding its integrity."

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Biotechnology Biosafety and Socio-economic Approaches
6th Ankara Biotechnology days will be held between 15-17 November in Ankara University Tandogan Campus 100. Yıl Conference Hall

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FDA has granted approval of IXEMPRA™ (ixabepilone) for breast cancer..

U.S. Food and Drug Administration (FDA) has granted approval of IXEMPRA™ (ixabepilone) as monotherapy for the treatment of patients with metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

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EU published the draft guideline for first-in-man clinical trials..

After the TGN 1412 disaster in 2006, the serious side effects experienced by volunteers Europe took an action to avoid the risk of such dramatic events recurring in a first-in-man trial.

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Pfizer withdraws inhaled Insulin..
Pfizer withdraws inhale insulin (Exubera) from the market. The decision was made based on low sales.

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FDA Acts to Ensure Thyroid Drugs Don’t Lose Potency Before Expiration Date..
The action is taken to ensure the drug retains its potency over its entire shelf life.  The data revealed a trend toward a loss of potency, with some preparations showing potency approaching 90 percent of labeled potency by the expiration date. Levothyroxine sodium products are used by over 13 million patients.

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ITAPS Basic GCP Course in Istanbul..
The first “BASIC GCP  COURSE” to be run by ITAPS (International training Academy of Pharmaceutical Sciences) will be held on 1-2 November 2007 at the CROWNE PLAZA HOTEL, İstanbul. The course will be in English.

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NEJM: Risk and Benefits of the CRO Boom
New England Journal of Medicine published a paper on the role of CRO's in Clinical trials. The paper states that CROs have  taken over much of academia's traditional role in drug development by offering greater speed and efficiency, but questions have been raised about their qualifications, ethics, accountability, and degree of independence

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FDA supports generic drugs..
To increase the number and variability of generic drugs FDA outlined a progam named GIVE (Generic Initiative for Value and Efficiency). The agency approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year.

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Report Finds Serious Problems with FDA's Oversight of Clinical Trials..
The report shows that FDA lacks the essential elements to adequately monitor clinical trials.

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Adverse events reported to the FDA.

According to an article published in Archieves of Internal Medicine , from 1998 through 2005, reported serious adverse drug events increased 2.6-fold, and fatal adverse drug events increased 2.7-fold.

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FDA Approved Evista (raloxifene hydrochloride) to reduce the risk of Invasive Breast Cancer in Postmenopausal Women
Evista is approved in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.

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Reply from the accused Turkish Authors
The authors accused of plagiarism in The Nature Journal replied claiming innocence. Click for the document (partly in English)..

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Nature: Turkish physicists face accusations of plagiarism
Almost 70 papers by 15 authors have been removed from the popular preprint server arXiv, where many physicists post their work. The moderators allege that the papers plagiarize the works of others or contain inappropriate levels of overlap with earlier articles.

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The Rosiglitazone Story published in New England Journal of Medicine

The chair of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) wrote about the committee discussions on rosiglitazone risk for the treatment of type 2 diabetes.

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Registration of Clinical Trials - New policies

Journal of the American Medical Association (JAMA) published a two-year evaluation of the registration of clinical trials  program required by ICJMA, and new policies are on the way.

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FDA approved a novel antiretroviral drug..

The U.S. Food and Drug Administration (FDA) approved an antiretroviral drug for use in adult HIV patients named Maraviroc. Maraviroc, sold under the trade name Selzentry, is the first in a new class of drugs designed to slow the advancement of HIV. Rather than fighting HIV inside white blood cells, maraviroc prevents the virus from entering uninfected cells by blocking the predominant route of entry, the CCR5 co-receptor.

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India rejects Novartis case..

The High Court in India, has agreed to uphold India's Patent Act in the face of a challenge by Swiss pharmaceutical company Novartis, in a court case that has been ongoing since January. The Indian Patent Act was designed to promote access to cheaper generic drugs for poor patients. 84% of antiretroviral drugs that MSF uses in clinics globally, for example, are Indian generics.

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ACRP is organizing a one day course on SOPs for Investigator Sites

This workshop is intended for Clinical Investigators, Sub-investigators and Clinical Research Coordinators (or anyone actively involved in conducting clinical research in hospitals or other research establishments).

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FDA approved restricted use of Tegaserod in Irritable Bowel Syndrome (IBS)..

The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.

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New links on the web page..
New links are added to the web page. You can find the list of insurance and reinsurance companies approved by the state and also the web page addresses of some University Ethical Committees. Please inform us of the data you want to see on our web page. 

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FDA Approves CustomVue Monovision LASIK
The CustomVue device is designed to correct all nearsightedness in the patient’s dominant eye and only part of the nearsightedness in the non-dominant eye. This allows the patient to use the fully corrected eye for distance vision and the under-corrected eye for seeing close up. After a period of time, the brain adjusts to the difference in perception between the two eyes.

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Insurance and reinsurance companies in Turkey
Name and web pages of the Companies approved by state is linked in our webpage.

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New set of Frequently Asked Questions and Answers on Informed Consent on DHSS website
The DHHS Office for Human Research Protections (OHRP) announces the availability of a new set of Frequently Asked Questions and Answers on Informed Consent on its website

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FDA has approved pregabalin (Lyrica) for treating fibromyalgia..
the drug is the first treatment for the condition; it was approved in 2004 for use in diabetic peripheral neuropathy and postherpetic neuralgia.

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Central Ethical Committee meeting..
The December meetings of the Central Ethical Committee will be on 04.12.2007 and 11.12.2007.

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EMEA and FDA agreed to expand their cooperation..
After the achievements in cooperation on vaccines, oncology, and pharmacogenomics; at a meeting in June 14-15, 2007, it was agreed to expand further the interactions in the areas of pediatrics and medicinal products for rare diseases (“orphan drugs”). Also, a “Principles of Interactions” document that will facilitate the timely exchange of information on scientific and ethical issues for pediatric therapeutics has been finalized.

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FDA Panel recommended FDA to reject rimonabant..

According to a news on Washington post taken from Associated Press, an advisory panel of experts recommended unanimously yesterday that the Food and Drug Administration reject a new weight-loss drug after hearing testimony that it increases the risk of suicidal behavior.

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Black-Box Warning on Heart Failure Risk with Glitazones
FDA revealed that the agency has requested that the manufacturers of rosiglitazone (Avandia) and pioglitazone (Actos) add black-box warnings about the risk for heart failure with these drugs.

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The draft of the new directive for budgeting the clinical trials in Turkey was sent to the Ministry of Finance..
The officlals commented that although the directive was well constructed; there is a remote possibility of approval by the Finance authorities

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New issue of IKU (Good Clinical Practice) Journal..
The last issue (No.16, 2007) is published with 2 main topics "CRO's in Turkey" and "Clinical research in different disciplines"

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A new hope for Renal Cell Carcinoma..
FDA approved a new enzyme inhibitor; Torisel (temsirolimus) for the treatment of Renal Cell Carcinoma.


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NEJM published the interim analysis of Rosiglitazone study -RECORD-
After the alert issued by FDA on the adverse cardiovascular risks of Rosiglitazone; interim analysis of RECORD study is published in New England Journal of Medicine. The authors stated that, the interim findings  were inconclusive regarding the effect of rosiglitazone on the overall risk of hospitalization or death from cardiovascular causes. There was no evidence of any increase in death from either cardiovascular causes or all causes. Rosiglitazone was associated with an increased risk of heart failure. The data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction.

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FDA Approves Contraceptive for Continuous Use..
Lybrel is 8 day-pill pack with low-dose combination tablets that contain 90 micrograms of a progestin, levonorgestrel, and 20 micrograms of an estrogen, ethinyl estradiol.

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FDA: safety alert on the use of Avandia (rosiglitazone) in Type II Diabetes Mellitus
FDA issued a safety alert on the use of Avandia (rosiglitazone) in Type II Diabetes Mellitus. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. There will be an article in the next issue of New England Journal of Medicine.

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European Commission invites member views on European Research Area (ERA)

In 2000, the EU decided to create the European Research Area (ERA). This means creating a unified area all across Europe. After 7 years, EC invites the members  of EU to give their opinion.



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Black box warning from FDA on the suicide risk of antidepressant agents..
FDA issued a warning on the increased suicide risk of antidepressant use. According to the warning risk of suicide and suicidal thoughts are increasng in patients between 18-24 years old. This risk decreases in patients between over 65 years old. This warning is followed several objections.
To read the article "Expanding the Black Box — Depression, Antidepressants, and the Risk of Suicide" click

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Important safety information on Cellcept by FDA..
Higher than expected incidence of acute rejection in cardiac transplant patients switched from calcineurin inhibitors in combination with CellCept
(mycophenolate mofetil) to Rapamune (sirolimus) in combination with CellCept at 12 weeks post heart transplantation caused FDA to issue an Important Safety Information

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High Prevalence of Physician-Industry Relationships Found in Survey
There is a "high prevalence" of relationships between U.S. physicians and pharmaceutical, medical-device, and other medical industries, a national survey finds.
The study, published in the current New England Journal of Medicine, was based on the responses of some 1700 physicians to a 47-item survey.


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Pfizer resuming TV consumer ads for Celebrex..
After the Vioxx withdrawal, Pfizer ceased the TV ads for Celebrex; a similar class drug. Now a 2.5 minutes long TV ad will be launched. 

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MHRA requested Bristol-Myers Squibb to recall a number of batches of Taxol 6 mg/ml..
At the request of the MHRA Bristol-Myers Squibb Pharmaceuticals is recalling a number of batches of Taxol 6 mg/ml Concentrate for Solution for Infusion (Paclitaxel) within expiry as a precautionary measure due to potential lack of sterility assurance. There have been no reports of non-sterile product and no sterility failures have been detected.

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FDA/DIA Workshop on Clinical Investigations
FDA's Office of Critical Path Programs and DIA are co-sponsoring a first-of-its-kind workshop on "Protecting Human Subjects Involved in Clinical Investigations: A Continuum from Design to Completion."

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FDA panel rejected the approval of a new COX-2 inhibitor..
FDA Panel Recommends Against New COX-2 Inhibitor
A new COX-2 inhibitor Arcoxia (etoricoxib)was rejected by FDA, because the drug was no more effective than naproxen and causes three times as many cases of stroke, heart attack, or death..
Arcoxia is currently available in 63 countries.

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China's deadly drug problem
The head of China's drug-safety agency is under investigation for alleged corruption.


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FDA has published a draft guidance entitled ‘‘Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting-Improving Human Subject Protection.’’
This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the Institutional Review Board.

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Second Education Meeting of the Clinical Research Associaton..
The evaluation of the Budget and Insurance in clinical trials will be the main topic of the meeting that will be held on 11 May 2007 in Ankara. Speakers and participants from Universities, State Hospitals, Social Security System,  Pharmaceutical companies, CRO's, govermental bodies and Insurance system will take part during the meeting.
For details click..



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Disclosure of payments do not provide easy access to payment information for the public
 According to an article in JAMA, in USA disclosure of payments made to physicians by pharmaceutical companies do not provide easy access to payment information for the public. In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years


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FDA Proposes new, tougher procedures for membership on advisory committees..
 The U.S. Food and Drug Administration (FDA) today announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation. FDA is accepting public comments on the proposal for the next 60 days.


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JAMA Article: Eligibility Criteria of Randomized Controlled Trials Published in High-Impact General Medical Journals
The authors selected 283 out of 4872 trials published in major medical journals to determine the nature and extent of exclusion criteria among RCTs and the contribution of exclusion criteria to the representation of certain patient populations. They stated that women, children, the elderly, and those with common medical conditions are frequently excluded from RCTs. Such extensive exclusions may impair the generalizability of RCT results.


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FDA issued an alert on Erythropoesis stimulating agents..
 According to the alert, darbepoetin (Aranesp) and epoetin (Epogen and Procrit) can increase the risk for cardiovascular and thromboembolic events, as well as shorten the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy.


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Position available in Pennsylvania, USA....
Our client is expanding and there are several key clinical development openings that include Medical Director positions in cardiology, oncology, pulmonary, ID, Neurology and Rheumatology. These are attractive career opportunities offering a competitive salary, flexible scheduling and a corporate culture of team work, dedication and quality results. Our client is based in Pennsylvania.

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First International Patient Safety Congress
 The First International Patient Safety Congress will be held in WOW Kremlin Palace Hotel (Kundu Village) in Antalya on 23-31st March 2007 with activities and working methodologies that support and complement each other from many aspects.


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FDA, has published a warning about Xolair
FDA, has published a warning about Xolair (omalizumab). The medicine belongs to the Company of Genentech. Xolair is used for the situations that steroids do not work for the allergen dependent asthma. But occurrence of the delayed anaphylaxis during the use of the medication resulted in the publishing of the warning. From now on, this warning will be written on the box of the medicine and in the prospectus of the medicine.



Contribution to clinical radiology studies
A research published in the Academic Radiology Magazine mentioned that Turkey has shown more contribution to clinical radiology studies recently.

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The bill about the establishment and the administrative functions of Turkish Drug and Medical Device Administration
The Turkish Drug Administration’s bill that is prepared by the Ministry of Health of Turkish Republic and Pharmaceutical General Directorate has been published with the name of “ the bill about the establishment and the administrative functions of Turkish Drug and Medical Device Administration.” You can reach whole text and read reviews from the news.



The first meeting of Clinical Research Association
The first meeting of Clinical Research Association was performed in Ankara at the date of 22 June 2006. The committee of management was elected and Prof. Dr. Murat Akova was elected new president. And Prof. Dr. Meral Tuncer was elected honorary president of our association



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