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FDA recommends device makers perform a statistical analysis based on gender for completed studies, according to a just-published f...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Unique Device Identification System: Small Entity Compliance Guide.[ Price : $8.95]
FDAs Cardiovascular and Renal Drugs Advisory Committee votes to recommend against approval of an Actavis NDA for a fixed-dose comb...[ Price : $8.95]
A Texas state jury awards a woman $73 million in damages for injuries suffered from a Boston Scientific transvaginal mesh device.[ Price : $8.95]
FDA warns CreAgri that its two Web sites are making drug claims for four Olivenol-branded unapproved drug products.[ Price : $8.95]
FDA publishes its Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Inter...[ Price : $8.95]
The Justice Department files two complaints under the False Claims Act against Michigan neurosurgeon Aria Sabit, spinal implant co...[ Price : $8.95]
Researchers writing in Milbank Quarterly say there appears to be a pro-sponsor voting bias among CDER advisory committee members w...