Harvard Medical School researchers say that in the last 30 years antimicrobial products have frequently qualified for FDA expedited clinical testing a...
Public Citizen calls for publication of federal contracts with five leading candidates to manufacture a Covid-19 vaccine, all of whom have received si...
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...