Researchers call on FDA to require postmarketing studies for breakthrough therapy-designated drugs studied with surrogate endpoints for traditional ap...
Abbott Diabetes Care begins a Class 1 recall (device correction) of its FreeStyle Libre 3 sensors based on users reporting situations where they were ...
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Three stakeholders ask FDA to modify a draft guidance on the agencys platform technology designation guidance.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.
