Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The FDA should incentivize sponsors to include minorities and other underrepresented groups in clinical trials and delay approving products whose evidence is based on less-inclusive trials, activists say. Read More
The European Medicines Agency has backed off of several controversial limitations it was considering imposing on sponsors of trials for treatments for chronic primary immune thrombocytopenia. Read More