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

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.

While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized.

CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”.

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.

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