Five Hogan Lovells attorneys analyze a new FDA draft guidance on clinical trial diversity action plans and urge companies to begin planning now to imp...
FDA publishes a draft International Conference on Harmonization M14 guidance on planning, designing, and analyzing observational pharmacoepidemiologic...
CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the Division of Ophthalmi...
FDA publishes a draft question-and-answer guidance to help firms address misinformation about their approved or cleared medical products.
FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.
FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery performance in device...
FDA says Philips Respironics has updated use instructions for three BiPAP ventilators in a Class 1 recall.
The Coalition for Sensible Safeguards calls on Congress to enact Chevron deference into law following a Supreme Court decision gutting the 40-year-old...
