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Federal Register Notice: FDA releases a final guidance: Guidance for Entities Considering Whether to Register as Outsourcing Facil...[ Price : $8.95]
Attorney Michael Walsh says that a New York federal court decision slapping down FDA attempts to bar Amarin from making truthful s...[ Price : $8.95]
Provensis asks FDA to revoke its PMA approval for Covidiens VenaSeal Closure System indicated for treating varicose veins.[ Price : $8.95]
FDA accepts for review a Teva Pharmaceutical Industries NDA for SD-809 (deutetrabenazine), indicated for treating Huntington disea...[ Price : $8.95]
FDAs Dallas District Office warns Royal Case Co. about QS violations in its role as manufacturer (initial importer) of cutaneous e...[ Price : $8.95]
FDA accepts for review a Takeda Pharmaceutical Co. and and H. Lundbeck A/S supplemental NDA seeking to add clinical data detailing...[ Price : $8.95]
Four firms tell FDA they are interested in participating in an agency-sponsored demonstration project to capture clinical trial da...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion warns Duchesnay about repeated marketing violations for its Diclegis associated with c...