FDA says it is preparing a significant update to its guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices....
FDA launches a revised Special 510(k) Pilot Program that aims to expand on the types of changes eligible for the program to improve the efficiency of ...
FDA Review posts the Federal Register notices for the week ending 9/28/2018.
Federal Register notice: FDA denies a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years from providing serv...
FDA issues a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Appli...
Federal Register notice: FDA issues a final order to reclassify single- use female condoms, renaming the device to single-use internal condom, a posta...
FDA issues two new draft guidance documents one on adaptive clinical trial designs and the other on master protocols that propose important principl...
FDA approves Pfizers Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of certain patients with metastatic non-small cell lung c...