FDA announces a 12/7 public workshop on quantitation of AAV-based gene therapy products.
FDA says the Vyaire Medical recall of 2,150 units of its Tri-Flo suction system is Class 1.
HelloLife recalls four homeopathic drug products due to microbial contamination.
Federal Register notice: FDA releases a final guidance entitled Physiologically Based Pharmacokinetic Analyses Format and Content.
Janssen files an NDA for esketamine nasal spray, indicated for treatment-resistant depression in adults.
Federal Register notice: FDA announces the charter renewal for two years of its Cardiovascular and Renal Drugs Advisory Committee.
Federal Register notice: FDA renews for two years the charter of the Endocrinologic and Metabolic Drugs Advisory Committee.
Stakeholders express general support for an FDA guidance on shared system REMS and offer suggestions for changes to it.