US FDA Patient Medication Information Proposed Rule May Be Coming Soon

A proposal for a new form of patient labeling, which has been in the works for decades, may finally be coming to fruition despite the FDA missing a December 2022 target date listed in HHS’ semi-annual regulatory agenda.

Sunrise over ocean
Decades in the making, the PMI proposed rule may be close on the horizon. • Source: Shutterstock

If the US Food and Drug Administration’s latest regulatory agenda is to be believed, the long-awaited proposed rule on Patient Medication Information labeling may be imminent.

The Health and Human Services Department’s semi-annual regulatory agenda, which will publish in the Federal Register on 22 February,...

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