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Attorney Michael Shumsky explains how a previously unknown FDA administrative change can allow NDA holders to gut the 180-day excl...[ Price : $8.95]
FDA warns Mexicos Glicerinas Industriales that its drug products are adulterated because the company refused to allow an FDA inspe...[ Price : $8.95]
Two Shook, Hardy attorneys say the 4th Circuit Court of Appeals has upheld a West Virginia law restricting ways in which plaintiff...[ Price : $8.95]
Federal Register notice: CBER announces a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Elect...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Non-Clinical Performance Assessment of Tissue Containment S...[ Price : $8.95]
An FDA advisory committee votes 9-3 to not recommend approval of an Acadia Pharmaceutical resubmitted sNDA for Nuplazid (pimavanse...[ Price : $8.95]
FDA denies a petition from the Informed Consent Action Network asking that it not approve Covid-19 vaccines for youths ages 12-17.