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 published recommendations for clinical trial designs for patients with bladder cancer, with separate considerations for patients with and without active disease. The agency’s draft guidance focuses on developing drugs and biologics for non-muscle invasive disease that has not responded to treatment with bacillus Calmette-Guerin immunotherapy. Read More
Officials from the FDA and the National Institutes of Health, in cooperation with public, private and industry stakeholders, published a framework for defining the levels of evidence needed to support the regulatory qualification of biomarkers for drug development. Read More
The European Medicines Agency made several changes to a March guidance explaining the agency’s policy for publishing sponsors’ clinical trials data, including factors that could lead to rejection. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for broader uses of research methodologies, such as intervention and randomization, in real-world settings outside the typical venues of clinical trials. Read More