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.
More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read More
The FDA issued a warning letter to Merrill Benson, a faculty member at Indiana University School of Medicine, over insufficient blood and panel testing of subjects observed at a clinical trial site following a Form 483. Read More
The Association of Clinical Research Professionals published its final Core Competency Framework for Clinical Study Monitoring, outlining the main skills needed throughout the clinical research associate workforce. Read More
The Association of Clinical Research Professionals and CRO Analytics announced a joint initiative to provide clinical research organizations with performance and quality measurements, and analysis of real-world data. Read More