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.
Fifteen FDA officials, including Commissioner Robert Califf, called for the broader uses of research methodologies in real-world settings, but cautioned against expectations for “quick wins” in efficiency and savings. Read More
CBER released a set of guidance topics that the center is considering for development this year, covering blood and blood components, tissues and advanced therapies, and chemistry, manufacturing and controls changes. Read More
HHS backed down from implementing its more controversial provisions in a broad overhaul of its Common Rule, including requiring researchers to obtain written consent before testing a donor’s biospecimens, even if the samples were presented with no personally identifying information. 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