This digest is a TL;DR version of current FDA-regulated Drug and Device news
- FDA Briefs: CDER, CDRH news
- Link and Learn: FDA initiatives
- Other: R&D information, FDA Meeting Debriefs
For FDA sponsored Public Meetings: Drugs, Devices, Advisory Committees
For Learning: CDERLearn, CDRHLearn
Recent Posts
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COVID news: SOTROVIMAB for emergency treatment, ACTEMRA for emergency use, Revoking EUA for non-NIOSH respirators, CARES Act for drug shortage mitigations, Updated vaccine risk information, EUA process infographic
Drug Authorizations: ADUHELM for Alzheimer’s, AMONDYS 45 for DMD, TEMBEXA for Smallpox, WEGOVY for weight management, TRUSELTIQ for cholangiocarcinoma, KLOXXADO for opioid overdose
News and Views: 2022 budget, Enhance Equity initiative, Enhance drug supply chain, Reg Science focus areas, OSEL updates, CURE ID platform expansion, Cosmetics regulation
DEVICE AUTHORIZATIONS: TALON SPACER for avascular necrosis, GILI biosensor for touchless heart and respiratory rates, GI GENIUS for colonic mucosal lesions, IPSIHAND for stroke rehabilitation
