FDA and the European Medicines Agency publish their collaborative 10 guiding principles for using artificial intelligence in drug development and eval...
FDA warns Austell, GA-based Anatomy Supply Partners about multiple types of violations in its manufacturing of the Safe-T-Fill Micro Capillary Collect...
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regul...
FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include adults with essentia...
Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agencys abil...
FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomerulosclerosis.
FDA classifies as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affected devices could r...
CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draft guidances on aspec...
