FDA posts a draft guidance entitled Postapproval Changes to Drug Substances.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 Review posts the Federal Register notices for the week ending 9/7/2018.
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs National Mammography Quality Assurance Advisory Committee.
FDA extends by three months the review of a Genentech supplemental BLA for Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab),...