Latest Federal Register Notices
Metal Expandable Biliary Stents Guide
Federal Register notice: FDA makes available a final guidance entitled “Metal Expandable Biliary Stents — Premarket Notification (510(k) Submissions.” 07/26/2019
Info Collection on Device Export Approval Letters
Federal Register notice: FDA sends to OMB an information collection extension for “Export of Medical Devices; Foreign Letters of Approval.” 07/25/2019
FDA Sets Generic Drug User Fee Rates
Federal Register notice: FDA sets the generic drug user fee rates for fiscal year 2020. 07/25/2019
Info Collection on Device Export Approval Letters
Federal Register notice: FDA sends to OMB an information collection extension for “Export of Medical Devices; Foreign Letters of Approval.” 07/25/2019
Comments Sought on Drug Development Glossary
Federal Register notice: FDA seeks comments on the agency’s publication of a glossary of terms which is part of the BEST (Biomarkers, Endpoints, and other Tools) Resource Taxonomy. 07/25/2019
Guide on Combo Product Postmarketing Reporting
Federal Register notice: FDA makes available a final guidance entitled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff.” 07/23/2019
Info Collection on Quick Turnaround Surveys
Federal Register notice: FDA sends to OMB a proposed information collection for quick turnaround surveys on communication effectiveness. 07/22/2019