Trump Administration senior associate counsel to the president Stacy Cline Amin moves to FDA to serve as chief counsel.
After years of resistance, FDA agrees to meet this week with injured LASIK patients seeking a ban on the lasers used in the controversial vision corre...
Federal Register notice: FDA announces a 10/18 Gastrointestinal Drugs Advisory Committee meeting to review a Shire NDA for a constipation drug.
FDA posts a draft guidance entitled Postapproval Changes to Drug Substances.
Federal Register notice: FDA determines that Corden Pharma Latinas Cefzil (cefprozil) tablets, 250mg and 500mg mg, and Cefzil for oral suspension,125m...
FDA approves a Teva 505(b)(2) NDA for Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence.
FDA issues GlaxoSmithKline a complete response letter for its supplemental BLA for mepolizumab as an add-on treatment to inhaled corticosteroid-based ...
FDA clears a Masimo 510(k) for the RAS-45, an acoustic respiration sensor for its Rainbow Acoustic Monitor (RAM) for infant and neonatal patients.