Federal Register Notice: FDA extends the comment period related to its public meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid...
Kyocera Medical Corp. receives 510(k) clearance for its Initia Total Hip System which features Bioceram Azul (blue) zirconia-toughened alumina ceramic...
Kite Pharma begins a rolling BLA submission for KTE-C19 (axicabtagene ciloleucel) as a treatment for patients with relapsed/refractory aggressive B-ce...
FDA posts a transcript of its 11/2 public meeting on Medical Device User Fee Amendments that discussed proposed recommendations for reauthorizing the ...
Federal Register Notice: FDA makes available a guidance entitled Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ...
Federal Register Notice: FDA seeks comments on an information collection extension request related to Medical Device: Current Good Manufacturing Pract...
Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection related to a recommended glossary and educational...
After almost 25 years at FDA, CDER Office on New Drugs director John Jenkins announces his retirement.