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A GAO report finds continuing internal CDRH disagreement with FDAs 2001 approval of a device made by TMJ Implants Inc., now fighti...[ Price : $8.95]
FDA clears a bioMrieux 510(k) for the Vidas Brahms PCT test for assessing a patients risk for developing severe sepsis.[ Price : $8.95]
Federal Register Proposed rule: FDA proposes to amend the biologics regulations by providing options for live vaccine processing r...[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on special protoco...[ Price : $8.95]
FDA approves an expanded indication for Sanofi Pasteurs Menactra, revising the age range down to include those between two and 10 ...[ Price : $8.95]
Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 12/11-12 to discuss an Astellas Pharma N...[ Price : $8.95]
Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 12/6 to discuss Prestwick P...[ Price : $8.95]
Federal Register Final rule: FDA amends it postmarketing reporting requirements to require an applicant who is the sole manufactur...