FDA posts Annual Forecast for Planned Monograph Activities

The Annual Forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to address.

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA posts Annual Forecast for Planned Monograph Activities Today, the US Food and Drug Administration posted the first Annual Forecast for Planned Monograph Activities. The Annual Forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to address over the upcoming three years.  Topics of planned monograph activities on this year's Annual Forecast include: Risks associated with codeine-containing cough medicine Pediatric acetaminophen dosing Risks associated with propylhexedrine abuse and misuse Nonsteroidal anti-inflammatory drugs and oligohydramnios Oral healthcare in infants and children Serious skin reactions associated with acetaminophen Anticaries test methods The Annual Forecast is a list of planned activities and is not a commitment from FDA that these activities will be addressed over the next three years. For more information about OTC Monograph Reform, visit FDA's webpage Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act. 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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