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CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”.