Attorney Michael Shumsky explains how a previously unknown FDA administrative change can allow NDA holders to gut the 180-day exclusivity incentive fo...
FDA warns Mexicos Glicerinas Industriales that its drug products are adulterated because the company refused to allow an FDA inspection.
Two Shook, Hardy attorneys say the 4th Circuit Court of Appeals has upheld a West Virginia law restricting ways in which plaintiff attorneys can adver...
Federal Register notice: CBER announces a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Electronic Submission Tem...
Federal Register notice: FDA makes available a draft guidance entitled Non-Clinical Performance Assessment of Tissue Containment Systems Used During P...
An FDA advisory committee votes 9-3 to not recommend approval of an Acadia Pharmaceutical resubmitted sNDA for Nuplazid (pimavanserin) for an indicati...
FDA denies a petition from the Informed Consent Action Network asking that it not approve Covid-19 vaccines for youths ages 12-17.