- DRUG AND DEVICE DIGEST

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

July 23, 2021 Drug & Device Advisory Group FDA Briefs

Thank you

July 7, 2021 Drug & Device Advisory Group FDA Briefs

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

June 10, 2021 Drug & Device Advisory Group FDA Briefs

Drug Authorizations: ADUHELM for Alzheimer’s, AMONDYS 45 for DMD, TEMBEXA for Smallpox, WEGOVY for weight management, TRUSELTIQ for cholangiocarcinoma, KLOXXADO for opioid overdose

June 7, 2021 Drug & Device Advisory Group FDA Briefs

News and Views: 2022 budget, Enhance Equity initiative, Enhance drug supply chain, Reg Science focus areas, OSEL updates, CURE ID platform expansion, Cosmetics regulation

May 12, 2021 Drug & Device Advisory Group FDA Briefs

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