FDA denies Sun Pharmas appeal of a complete response letter for its Taclantis NDA and asks for a new Phase 3 study.
FDA voices its specific concerns with compounded drugs being used to treat patients with Covid-19.
Attorney Carolina Wirth says a recent FDA Webinar on monograph reform included timeframes that indicate reform will take several years to complete.
Federal Register notice: FDA posts a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including Dur...
Federal Register notice: FDA extends the comment period on a 1/11 notice requesting comments regarding a document entitled Potential Approach for Defi...
Federal Register notice: FDA sends to OMB an information collection extension for Adverse Experience Reporting for Licensed Biological Products and Ge...
The CDER Office of Prescription Drug Promotion warns CooperSurgical that a Paragard promotional video fails to communicate any risk information.
FDA denies a Synergy Pharmaceuticals petition asking that it order Forest Laboratories to make changes to the Linzess prescribing information.