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Category: Over the Counter (OTC)

OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA

OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA

OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA

US FDA releases 5 New Over the Counter (OTC) Monographs (final orders)

US FDA releases 5 New Over the Counter (OTC) Monographs (final orders)

In May 2023, the U.S. Food and Drug Administration issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.

US-FDA Publishes New Requirements for OTC Drugs Labeling

On September 8,2022, FDA published the draft of a guideline that provides recommendations on the labeling of OTC drugs.

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