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FDA publishes a final guidance with recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty ba...[ Price : $8.95]
GlaxoSmithKline asks the Supreme Court not to hear Tevas appeal of an adverse appeals court decision in a skinny label case for it...[ Price : $8.95]
Federal Register notice: FDA issues a final order to exempt certain categories of biological products from certain annual reportin...[ Price : $8.95]
FDA accepts for review a AlgoDx de novo marketing request for Navoy Sepsis, a clinical decision support software for predicting se...[ Price : $8.95]
FDA says a Philips Web site report on the number of replacement and remediated BiPAP and CPAP devices shipped to consumers oversta...[ Price : $8.95]
The Justice Department seeks emergency relief from the U.S. Supreme Court after the Fifth Circuit Court of Appeals ruled that the ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Over-the-Counter Monograph Order Requests (OMORs): Format a...[ Price : $8.95]
Federal Register notice: FDA announces a request for information and comments on the development of an FDA data and technology str...