February 16, 2011- by Steven Greer, MD
In Part 1 of our interview with Margaret Hamburg, MD, The Commissioner of the FDA, she discusses the challenge of globalized medical manufacturing and clinical trials. More than just adding to inspections, a new paradigm is needed.
In Part 2, Dr. Hamburg discusses the FDA’s plans to streamline U.S. clinical trials, in conjunction with academic medical center consultation. She then concludes by discussing the new CDRH initiative to fast track certain medical devices deemed to be of extraordinary innovative quality and medical benefit.