CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draft guidances on aspec...
FDA warns Indias Chemspec Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns Purushothaman Kumaran about failing to follow the investigational plan for a bioequivalence study at a hospital in Pondicherry, Puducherry, ...
FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for their weight loss dr...
FDA issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics investigational cell therapy for...
A new JAMA analysis finds that FDAs regulation of mifepristone has been driven largely by scientific evidence and internal expert judgment, with limit...
FDA accepts for review an EMD Serono NDA for pimicotinib, a potential first-in-class systemic treatment for tenosynovial giant cell tumor.
FDA articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the agency says is intende...
