India-based Aurobindo Pharma says that a recent FDA inspection at its Dayton, NH, AuroLife Pharma unit resulted in a Form 483 citing nine GMP observat...
A lengthy Politico article sees the return of CBER director Peter Marks to full-time FDA duty from Operation Warp Speed as one example of political in...
FDA issues a compliance guide for inspections of CDER-led and CDRH-led combination products.
FDA accepts for review a PharmaEssentia BLA for ropeginterferon alfa-2b (P1101), a novel pegylated interferon intended for treating rare blood cancer ...
FDA approves a Merck NDA for Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventil...
FDA issues an immediately-in-effect guidance on IRB procedures and factors to consider for individual patient expanded access requests during the publ...
FDA extends by three months its review of a Novartis supplemental BLA for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patie...
Federal Register notice: FDA posts additional draft and revised draft product-specific guidances on bioequivalence study designs to support ANDAs.