FDA posts its Prescription Drug User Fee Act VII commitment letter that describes enhancements to the program that will take place beginning 10/1/2022...
FDA Review posts the Federal Register notice for the week ending 8/20/2021.
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FDA posts a revised draft guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.FDA posts a revise...