Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses of medical products.
FDA warns Dr. Melanie Hoppers/Physicians Quality Care in Jackson, TN, about violations in two clinical investigations at her study site.
FDA commissioner Robert Califf says there have been discussions about whether public funding should be used to support some key postmarketing evidence...
Due to concern about microbial contamination, Bayer recalls one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles.
A bipartisan group of nine senators ask FDA what it is doing to revise its animal testing regulations to be consistent with the FDA Modernization Act ...
FDA approves a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension.
FDA delays a 12/16-expected review decision on a Bristol Myers Squibb and 2seventy bio supplemental BLA for Abecma (idecabtagene vicleucel) and its us...
Federal Register notice: FDA announces a 12/14 public meeting entitled Advancing the Development of Therapeutics Through Rare Disease Patient Communit...
