Monograph Reform

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CHPA looks forward to working closely with FDA and other key stakeholders throughout the OMUFA reauthorization process as we work together to ensure the continued success of FDA’s OTC monograph program.

Oct 27, 2023

Timeline for FDA consideration of changes to the general recognition status of an OTC monograph ingredient under the standard procedure

Oct 20, 2023

CHPA tracks FDA progress vs. OMUFA goals and activities referenced in legislation. These goals were negotiated between the Agency and Industry prior to the legislation and cover the 5-year period for OMUFA I (October 1, 2020 – September 30, 2025).

Mar 9, 2023

This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Nov 7, 2022

Comments regarding Citizen Petition from Greenberg Traurig requesting that FDA issue the administrative order for OTC external analgesics, and that FDA confirm and clarify for which specific indications OTC external analgesic drug products in patch/plaster/poultice dosage forms are generally recognized as safe and effective.

Aug 10, 2022

House and Senate negotiators are at odds over how to move forward with the FDA user fee reauthorization now that Senate HELP Committee Ranking Member, Senator Richard Burr (R-N.C.) is pushing a significantly pared-down version of the user fee reauthorization bill.

Jul 19, 2022

Now that the House of Representatives and the Senate HELP Committee have passed their respective FDA user fee bills, House and Senate negotiators have been working to conference and reconcile differences in both bills.

Jul 6, 2022

CHPA’s President & CEO, Scott Melville, released a statement in response to the FDA Safety and Landmark Advancement (FDASLA) Act of 2022.

May 18, 2022

While this week both the House and Senate are on recess, last week the Senate HELP Committee began the process of meeting to discuss and ultimately pass the Prescription Drug User Fee Act (PDUFA).

Apr 12, 2022

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