FDA warns Chinas Foshan Miwei Cosmetics Co. about CGMP violations in its production of three misbranded unapproved new over-the-counter drugs.
FDA warns Intas Pharmaceuticals Limited about CGMP violations in its production of finished drugs at the manufacturing facility in Selaqui, Dehradun, ...
FDA accepts for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for warm autoimmune hemoly...
FDA moves to increase pressure on Amgen to withdraw approval of autoimmune disease drug Tavneos (avacopan), concluding that the therapy lacks reliable...
FDA seeks to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a broader pilot program...
A Quality Magazine article explains what FDA investigators have focused on in their initial Quality Management System Regulation inspections.
FDA releases the form FDA-483 issued after a 2024 inspection at the Excelvision drug manufacturing facility in Annonay, Ardche, France.
FDA grants a fast track designation to Scancells advanced melanoma investigational drug iSCB1+.
