Unreported Side Effects of Drugs Are Found Using Internet Search Data...
Using data drawn from queries entered into Google, Microsoft and Yahoo search engines, scientists at Microsoft, Stanford and Columbia University have for the first time been able to detect evidence of unreported prescription drug side effects before they were found by the Food and Drug Administrations warning system.
The FDA has published its 33rd edition of the Orange Book. The book is widely used in the regulatory community for identifying which drug products are substitutable for one another. The book contains all drug products that are approved or have not been withdrawn for reasons of safety or efficacy with the exception of products marketed before 1938
New EMA guideline on the investigation of drug interactions..
This guideline outlines a comprehensive, systematic and mechanistic approach to the evaluation of the interaction potential of a drug during its development and offers guidance to ensure that the prescriber receives clear information on the interaction potential as well as practical recommendations on how the interactions should be managed during clinical use.
As clinical trials are performed under specific conditions, there is always a debate on whether the results of a clinical trial reflects daily practice. A modest reply to that question comes from an article published in JAMA.
Partnerships in Clinical Trials Russia-CIS & MENA-Turkey...
Partnerships in Clinical Trials Russia-CIS & MENA-Turkey'' meeting will be held in Renaissance Polat Istanbul Hotel, Istanbul on 22-23 May 2013. There will be additional benefits for our website members.
FDA required the manufacturer of the smoking cessation drug varenicline to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug, and
is informing the public about the results of a meta-analysis that compared patients who received the smoking cessation drug varenicline to patients who received a placebo.
2012 Performance Analysis of the Global Medical Technology Industry: Ernst & Young Report..
In this report, medical technology (medtech) companies are defined as companies that primarily design and manufacture medical technology equipment and supplies and are headquartered within the United States or Europe. For the purposes of this report, we have placed Israels data and analysis within the European market, and any grouping of the US and Europe has been referred to as global.
A new draft guidance published by the US Food and Drug Administration (FDA) aims to clarify the responsibilities of institutional review boards (IRBs) in the oversight of investigators, research sites and investigational authority of sponsors.
The International Compilation of Human Research Standards avaialable..
The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations. Many of the listings embed hyperlinks to the source document.
Nine Italian cardiologists arrested for fraud and misconduct...
Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. Several news reports mentioned that stents and angioplasty balloons were involved.
The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called "Pharmaceutical Quality System".
FDA announced Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications.
FDA Adopts ICH Guidance on Pharmaceutical Quality..
The US Food and Drug Administration released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan.
ESHLSG Guidelines on transparency in clinical research.
The Ethical Standards in Health and Life Sciences Group (ESHLSG) published the principles of transparency in clinical research in a guideline. This is a joint effort of health care professionals and pharmaceutical industry.
From FDA: Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval..
This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations.
An article in Archieves of Internal Medicine is describing the off-label drug use in Canada. According to the article, the prevalence of off-label use was 11.0%; of the off-label prescriptions, 79.0% lacked strong scientific evidence.
The EFGCP Report on Research Projects in Europe; Turkish paragraph....
The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe; Turkish paragraph is finalized (English). You can find the answers to most of your questions in this document.
EMA GVP modules are available for public consultation..
New legislation for pharmacovigilance will apply in the European Union as of July 2012, and the first 7 modules of the guidelines for the conduct of pharmacovigilance in the EU are now available for public consultation.
Basic statistics of Clinical trials in Turkey can be found in the attached document. The figures are from the manuscript published in Turkish GCP Journal (
) by Hilal İlbars from MoH.
The guidance is prepared in order to promote biosimilar drug development and enhance competition. As outlined in the draft guidance, FDA recommends a stepwise approach in the development of biosimilar products.
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients.
Emergency Hospitalizations for Adverse Drug Events in Older Americans..
A study published in New England Journal of Medicine showed that emergency hospitalization for Adverse Drug Events in Older Americans mainly resulted from commonly used antitrombotic or anti diabetic drugs. Improved management of antithrombotic and antidiabetic drugs has the potential to reduce hospitalizations for adverse drug events in older adults.
All guidelines related to Clinical Research are now in English..
The guidelines that are active at this moment are translated to English by Association of Research-Based Pharmaceutical Companies (AIFD) and Association of Contract Research Organization Companies (SAKDER). You can reach the guidelines from our
from the Documents menu on the left, following the
link. Read the news to see the list of the Guidelines.
NIH dropped the Conflict Disclosure Plan for universities..
The plan would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers by using a web page.
PharmaVoice, June 2011, article related to Turkey...
According to the article, Local R&D activity is gaining higher priority and resulting in a higher volume of clinical trials conducts in Turkey. Local and multinational companies are opening more R&D centers and engaging in scientific research partnerships. But the article also states that there are some obstacles to overcome.
The Centre for Medicines Research International has noted that the average for the combined success rate at Phase III and submission has fallen to ~50% in recent years. There were 83 Phase III and submission failures between 2007 and 2010.
The US Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) approved 15 new molecular entities and 6 new biologics in 2010. The total of 21 new products falls below the 25 approved in 2009 and the 24 in 2008.
A neuroscientist in Denmark who had published over 100 peer-reviewed articles has resigned after facing allegations that she committed research misconduct and misspent grant money. The University of Copenhagen has also recently paid back more than 2 million Danish kroner of the IMK General Fund grant that the foundation awarded to Penkowa. She left her position in the University after the accusations.
The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency.
The 2011 Edition of the International Compilation of Human Subject Protections has been posted..
The 2011 Edition features a listing of over 1,000 laws, regulations, and guidelines on human subject protections in 101 countries. New countries added this year are Belarus, Grenada, Pakistan, Rwanda, and Tunisia.
This year’s Compilation also features the standards regarding device research, which were located in 44 countries.
EMA report on trial participation and site inspections between 2005-2009..
61% of the patients who took part in the pivotal clinical trials used to support marketing authorisation applications submitted to the EMA between 2005 and 2009 came from third countries. Since 1997, GCP inspections have been requested for only 228 of the 44,034 investigator sites counted as part of the pivotal trials.
Hillary Clinton apologized for human research conducted in Guatemala..
The experiment, carried out in the 1940′s, was the act of inoculating prisoners, soldiers and mental patients with syphilis, without their knowledge or permission. Also Bill Clinton apologized for the Tuskegee study when he was the president of the USA. Tuskegee study was performed on African Americans with syphilis.
MedicReS International Conference on Good Medical Research..
"GOOD MEDICAL RESEARCH" titled International Conference of MedicReS is to take place in March 25-27, 2011 in Istanbul. Medical Researchers: AUTHORS, EDITORS, REVIEWERS from Turkey and abroad are to attend to the congress.
The aim of the congress is to discuss ETHICAL, HISTORICAL, BIOSTATISTICAL, METHODOLOGICAL, ECONOMICAL and LEGAL approaches to medical research with regard to the international standards in "GOOD PLANNING-GOOD ANALYZING-GOOD REPORTING-GOOD REVIEWING" main titles
GSK Opens Vaccine Clinical Research Center in Hacettepe Teknokent
GlaxoSmithKline (GSK) has opened Turkey’s first Vaccine Clinical Research Center in cooperation with Hacettepe University Teknokent A.Ş. GSK Vaccine Clinical Research Center will facilitate participation to international clinical studies from Turkey, as well as realization of national research projects.
New FDA safety website for drugs with no problems..
The US FDA opened a new website on 15 June that provides the public updated information on drug safety with a major difference: unlike other FDA safety notification systems, this one spotlights not only reasons for caution, but also the far more frequent instances when a new drug has been found to have no unexpected safety concerns. The site is designed to be accessed by the general public as well as healthcare professionals.
EC proposal on new clinical trial rules not expected until late 2011 ..
The European Commission says that the consultation exercise on the review of the EU clinical trials directive has yielded some useful information on the shortcomings of the legislation and that it is now looking at the various policy options for tackling them.
The following guidelines are on now our webpages in English:
Guideline on Independent Data Monitoring Committees
Guidance on Observational Studies with Drugs
Guidance for the Preparation of Good Clinical Practice Inspection Reports
Guidance on the Format of Applications to the Ministry for a Clinical Trial
Guidance on Ethical Considerations for Clinical Trials on Medicinal Products with the Pediatric Population
Know-how transfer from Turkey to UAE in clinical research
as a continuous GCP training program that has reached 800 health personnel in Turkey since 2003, has accepted its first foreigner investigators to the programme in 2008 in Istanbul. In 2009, the success that AkademiKA
achieved abroad, turned into a special training demand from United Arab Emirates.
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.
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.
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.