Five Hogan Lovells attorneys analyze a new FDA draft guidance on clinical trial diversity action plans and urge companies to begin planning now to imp...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FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 8.
FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Supplies outsourcing f...
FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marne-cel) for treating ...
