Just-released minutes describe industrys overall proposal for the MDUFA 5 agreement.
Merck calls on FDA to consider using a variety of methods to assess clinical pharmacology for peptides.
FDA accepts the first HDE module submitted by Invivo for its Neuro-Spinal Scaffold implant.
FDA warns Halodine it is marketing unapproved and misbranded non-alcohol-based antiseptic products for Covid-19.
Johnson & Johnson discusses with FDA and other regulators rare cases of Guillain-Barré syndrome that have been reported following vaccination wi...
FDA posts a guidance that answers common questions about the end of the compliance and enforcement policy for certain human cells, tissues, or cellula...
Federal Register notice: FDA corrects a 12/2/2019 notice announcing the withdrawal of 21 ANDAs from multiple applicants.
FDA approves a Janssen Biotech BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for cer...