Monograph Reform

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While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized.

Jun 14, 2016

Unlike other drugs subject to user fees, nonprescription drugs under the Monograph system are not subject to FDA approval prior to marketing. Many of these ingredients have been marketed for more than 40 years, with a long history of safe use. We must define value differently than industries subject to FDA approval prior to marketing.

Jun 10, 2016

CHPA issued the following statement following the Food and Drug Administration’s announcement of a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription monograph drugs.

May 10, 2016

CHPA spoke today before a Food and Drug Administration Advisory Nonprescription Drugs Advisory Committee, during which the committee discussed data submitted by Galderma Laboratories, L.P. to support the supplemental new drug application for over-the-counter marketing of adapalene gel 0.1%.

Apr 15, 2016

CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”.

Jun 3, 2015

CHPA applauds and is strongly supportive of FDA's re-examination of the monograph system in an effort to complete the OTC Drug Review.

May 8, 2014

CHPA and its member companies strongly support the OTC Monograph System, which effectively and efficiently regulates the majority of OTC medicines on the U.S. market.

Mar 25, 2014

Letter to Dr. Shawn Dressman regarding U.S. Pharmacopeia's Stimuli article: USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities.

Mar 29, 2013

CHPA comments on proposed recommendations for the reauthorization of the Prescription Drug User Fee Act.

Oct 31, 2011

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