This blog provides another perspective on the FDA's adoption of ISO 13485 as the new Quality Management System Regulation (QMSR)...

Dr. Jeffrey Shuren, Director of the US FDA's Center for Devices and Radiological Health (CDRH), stepped to the podium on May 15, 2024, at...

The Food and Drug Law Institute's annual meeting on May 15-16, 2024, had an element of artificial intelligence (AI) throughout many...

FDA's Commissioner calls on everyone to fight misinformation and allocate time for the betterment of the country and its citizens.

The Food and Drug Law Institute (FDLI) is on day two of the Enforcement, Litigation and Compliance conference. The annual meeting always...

Once upon a time, long before FDA use the MAPP (Manual of Policies and Procedures) to tell us where they are going, a young investigator...

If you work in the medical device arena and have products in the US, then you are likely familiar with the FDA’s Quality System...

Both during and after my career at FDA, individuals have asked me, “As an FDA investigator what are you looking for when…?”. I thought...

If you work in pharma, biotech, medical devices, or any other industry regulated by the FDA, I feel safe in saying you probably have had,...