FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs    The U.S. Food and Drug Administration posted an initial batch of four deemed final administrative orders (deemed final orders) issued as part of Over-the-Counter (OTC) Monograph Reform under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The first four deemed final orders include: Nighttime Sleep-Aid Drug Products for OTC Human Use Antiflatulent Drug Products for OTC Human Use Topical Otic Drug Products for OTC Human Use Corn and Callus Remover Drug Products for OTC Human Use The FDA will post deemed final orders using a phased approach on the FDA's new IT system, OTC Monographs@FDA. Learn more The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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