An FDA inspection of a Global Calcium manufacturing facility in Hosur, India leads to a six-observation Form FDA-483 that cites significant GMP violat...
Federal Register notice: FDA announces a 10/30 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on patient-cen...
Three stakeholders ask FDA to modify a draft guidance on the agencys platform technology designation guidance.
FDA warns Durham, NC-based CARsgen Therapeutics about CGMP violations in its production of investigational drugs and biologics used in a Phase 2 trial...
Federal Register notice: FDA announces the issuance of an emergency use authorization for Octapharmas freeze-dried plasma product, octaplasLG Powder, ...
FDA warns Watertown, MA-based EyePoint Pharmaceuticals about CGMP violations in its production of finished drugs.
FDA approves an llumina PMA for its in vitro diagnostic TruSight Oncology Comprehensive test for two companion diagnostic indications.
FDA explains its rationale for making six changes to the emergency use authorization for Invivyds Pemgarda Covid-19 pre-exposure prophylaxis agent.
