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Federal Register notice: FDA makes available a draft guide entitled Master Protocols: Efficient Clinical Trial Design Strategies t...[ Price : $8.95]
Oscor Inc. recalls its TB Temporary Bipolar Pacing Lead (unshrouded 2 mm Pins Models) due to connectivity concerns.[ Price : $8.95]
Ventana Medical Systems recalls (Class 1) multiple detection kits due to a potential for false negative results caused by reagent ...[ Price : $8.95]
FDA says it is preparing a significant update to its guidance on Content of Premarket Submissions for Management of Cybersecurity ...[ Price : $8.95]
FDA launches a revised Special 510(k) Pilot Program that aims to expand on the types of changes eligible for the program to improv...[ Price : $8.95]
Federal Register notice: FDA denies a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years...[ Price : $8.95]
FDA issues a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Dru...[ Price : $8.95]
Federal Register notice: FDA issues a final order to reclassify single- use female condoms, renaming the device to single-use inte...