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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FDA issues a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Dru...[ Price : $8.95]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...[ Price : $8.95]
FDA issues two new draft guidance documents one on adaptive clinical trial designs and the other on master protocols that propos...[ Price : $8.95]
FDA approves Pfizers Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of certain patients with metastatic n...[ Price : $8.95]
Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) introduce Making Objective Drug Evidence Revisions for New(MODERN) Labeling ...