Friday, October 1, 2021

FDA Posts Annual Forecast for Planned Monograph Activities - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

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.


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