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US FDA Forecasts Monograph Program Activities As Overhaul Transitions From Construction Phase

 
• By Malcolm Spicer

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.

• Source: Shutterstock

Codeine’s status as an OTC drug under US federal regulations continues as an item on the Food and Drug Administration’s latest annual list of planned OTC monograph activities it intends to initiate over the next three years.

The list published on 30 September, the fourth for the program, likely will be the final annual nonbinding forecast under...

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More from Policy & Regulation

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