FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.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 recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its Huntingtons disease ...
Merck says that adding Welireg (belzutifan) to Keytruda as adjuvant therapy significantly reduced the risk of disease recurrence or death in certain p...
