Thursday, August 20, 2015
The second draft of the proposed 21st Century Cures Act—which aims to accelerate the discovery, development and delivery of next-generation health products—includes a significant increase in NIH funding, expansion of an FDA patient-focused drug development initiative and removal of some drug exclusivity provisions.
Robert Califf, M.D., vice chancellor of clinical and translational research at Duke University, not only was named the FDA’s new deputy commissioner for medical products and tobacco. He’s also now a potential candidate for the top FDA post, following FDA Commissioner Margaret Hamburg’s announcement late last week that she will be stepping down.
Vince & Associates Clinical Research, a clinical research services company based in Overland Park, Kan., has been awarded a contract with the FDA’s Center for Drug Evaluation and Research (CDER) to conduct bioequivalence studies of innovator and generic drugs such as anti-epileptic drugs.
The Clinical Trials Transformation Initiative (CTTI) has named a 14-member executive committee, resetting CTTI’s strategic direction and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.
A strengthened and modernized post-market drug safety program has resulted in a substantial improvement in the FDA’s oversight of drugs once they reach the American public, according to a new report by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to post-market drug safety monitoring as to premarket drug review.