FDA Review posts product approval summaries for the week ending 8/20/2021.
Federal Register notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 ...
FDA issues a safety alert reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical devices for ...
FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurre...
Federal Register notice: FDA sends to OMB an information collection revision on human drug compounding, repackaging, and related activities.
FDA posts a revised draft guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.FDA posts a revise...
The Biden Administration reportedly rules out nominating FDA acting commissioner Janet Woodcock for the agencys top post due to lawmakers objections....
CDER drug promotion researchers evaluate how images can offer misleading perceptions in direct-to-consumer drug ads, and develop validated instruments...