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CDRH issues three guidances on using consensus standards to satisfy premarket review requirements.[ Price : $8.95]
FDA approves an AstraZeneca supplemental NDA for Seroquel XR (quetiapine fumarate) and its expanded use as maintenance treatment i...[ Price : $8.95]
Gilead Sciences submits an NDA for aztreonam lysine for inhalation (75 mg three times daily), an investigational therapy for treat...[ Price : $8.95]
Sen. Chuck Grassley says GlaxoSmithKline tried to intimidate a university researcher who raised early questions about Avandia safe...[ Price : $8.95]
Former FDA deputy commissioner for medical and scientific affairs Scott Gottlieb says organizational changes are needed at FDA to ...[ Price : $8.95]
FDA orders the seizure of Jan Marini Skin Researchs Age Intervention Eyelash in San Jose as an unapproved and misbranded drug that...[ Price : $8.95]
Consulting editor John Scharmann responds to FDA field employees comments on his recent article, FDAs Foreign Model Could be Good ...[ Price : $8.95]
FDA clears a Medtronic 510(k) for the Complete SE (self-expanding) Biliary Stent System, indicated for use in the palliative treat...