User Fees

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Article

What follows is a timeline for implementation of OTC monograph reform under HR 748, also known as the CARES Act.

Jun 23, 2020

Press Releases and Statements

We are encouraged by the ongoing, bipartisan momentum behind this reform and look forward to seeing the legislation move forward in the House as well as the Senate.

May 9, 2018

Press Releases and Statements

Today, the United States Senate Health, Education, Labor and Pensions (HELP) Committee approved S. 2315, the Over-the-Counter Drug Safety, Innovation, and Reform Act by a 22-1 vote.

Apr 4, 2018

Press Releases and Statements

CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive, and accommodating to innovation.

Jul 12, 2016

Submission

While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized.

Jun 14, 2016

Press Releases and Statements

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

Press Releases and Statements

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

Submission

CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”.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

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