FDA seeks public input on whether to revise a longstanding series of manufacturing guidance documents that govern how drugmakers manage postapproval c...
FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.
FDA sends 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 medications on their Web sites.
FDA publishes the International Council for Harmonization M14 guidance on planning, designing, analyzing, and reporting non-interventional studies usi...
FDA publishes the International Council for Harmonization E2D(R1) guidance on management and reporting of postapproval individual case safety reports.
FDA posts the form FDA-483 issued following a 2024 inspection at Japans Fukuzyu Pharmaceutical Co.
FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad misleading and viola...
FDA posts a complete-response letter that outlined last month's rejection of Regenxbios BLA for its gene therapy clemidsogene lanparvovec.
