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Attorney Suzanne OShea says Congress needs to clarify its intent so FDA knows how to classify combination products for review eith...[ Price : $8.95]
CDRH associate director for international affairs Kimberly A. Trautman says an FDA-backed medical device single audit program shou...[ Price : $8.95]
President Obamas science and technology advisors release a report and strategy on combating antibiotic resistance.[ Price : $8.95]
FDA clears an Intuitive Surgical 510(k) for its da Vinci S and da VinciSi Surgical Systems and their use in benign, base-of-tongue...[ Price : $8.95]
FDA approves an Eli Lilly NDA for Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control in adu...[ Price : $8.95]
A joint FDA advisory committee panel votes 18-3 that the overall benefit/risk profile of Rextoro (testosterone undecanoate) was no...[ Price : $8.95]
Federal Register Proposed order: FDA proposes to reclassify salivary stimulatory system into Class 2.[ Price : $8.95]
Federal Register Final order: FDA classifies tryptase test system devices into Class 2.