[ Price : $8.95]
FDA seeks public input on whether to revise a longstanding series of manufacturing guidance documents that govern how drugmakers m...[ Price : $8.95]
FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions a...[ Price : $8.95]
FDA sends 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 medications on t...[ Price : $8.95]
FDA publishes the International Council for Harmonization M14 guidance on planning, designing, analyzing, and reporting non-interv...[ Price : $8.95]
FDA publishes the International Council for Harmonization E2D(R1) guidance on management and reporting of postapproval individual ...[ Price : $8.95]
FDA posts the form FDA-483 issued following a 2024 inspection at Japans Fukuzyu Pharmaceutical Co.[ Price : $8.95]
FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad ...[ Price : $8.95]
FDA posts a complete-response letter that outlined last month's rejection of Regenxbios BLA for its gene therapy clemidsogene lanp...