Latest Federal Register Notices
Comments Extended on Combo Product Bridging Guide
Federal Register notice: FDA extends until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combination Products. 02/14/2020
28 ‘No Longer Marketed’ ANDAs Withdrawn
Federal Register notice: FDA withdraws approval of 28 ANDAs from multiple applicants. 02/14/2020
Guide on Peripheral Vascular Atherectomy Device PMAs
Federal Register notice: FDA posts a final guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification Submissions.” 02/13/2020
FDA Seeks Nonvoting Patient Engagement Panel Members
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve as temporary nonvoting members on CDRH’s Patient Engagement Advisory Committee. 02/13/2020
Info Collection on Rapid Response Surveys
Federal Register notice: FDA seeks comments on an information collection extension for “FDA Rapid Response Surveys.” 02/12/2020
Meeting on Drug Development for Vitiligo
Federal Register notice: FDA announces a 3/30 public meeting entitled “Patient-Focused Drug Development for Vitiligo.” 02/11/2020
Info Collection on Device Risk Allegations
Federal Register notice: FDA seeks comments on an information collection entitled “Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health.” 02/10/2020