Federal Register notice: FDA denies a request for a hearing submitted by Vithal K. Patel and issues an order debarring him for one year from providing...
Federal Register notice: FDA denies Belen G. Ngos request for a hearing and is issuing an order debarring her for five years from providing services r...
FDA approves an AstraZeneca BLA for Saphnelo (anifrolumab-fnia) for treating adult patients with moderate to severe systemic lupus erythematosus.
Federal Register final rule: FDA issues a final rule to amend its medical product intended use regulations.
FDA Review posts the latest Federal Register notices for the week ending 7/30/2021.
Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022.
Federal Register notice: FDA announces a 10/7 Antimicrobial Drugs Advisory Committee meeting to discuss Takeda's maribivir.