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The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety, biosimilars development and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More
The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. The official request, due 20 days later, should include the procedure number and a detailed justification for requesting the reexamination, according to updated guidance issued Jan. 22. Read More
The European Medicines Agency plans to bar sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
India has finalized the formulas sponsors must use to determine compensation for patients who are injured during clinical trials, and one expert says they will do little to attract trials back to the country. Read More
Sponsors and investigators will share responsibilities for gathering and reporting clinical trial information on clinicaltrials.gov, if a November proposed rule is finalized. Read More
Experience levels of principal investigators fluctuate wildly the world over, a fact that could put promising research at risk, according to a Tufts University report on protocol noncompliance rates and principal investigator turnover. Read More