OTC Monograph User Fees, Pre-submission Meetings and Electronic Submissions Possible

Although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become law. Assuming passage, OTC User Fees and electronic submissions will be required and sponsors will have the opportunity to engage in pre-submission meetings with FDA before requesting changes to OTC monographs. The process for effecting such changes will be known as Over-the-Counter Monograph Requests (OMORs).

If OMUFA is not included in this year’s legislative agenda, it won’t be going away. FDA plans a Webinar on August 23, 2017 from 12:30pm-2:00pm to provide stakeholders with a status update. For a more detailed discussion, see our latest paper entitled FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions.

PDG has significant experience in the strategic product development of nonprescription (OTC) products, including both monograph and NDA pathways. This includes 505(b)(2) submissions for both OTC approval and Rx-to-OTC conversions as well as drafting Citizen Petitions and comments to various dockets. Our proficiency and expertise extends to establishment registration and product listings (NDC codes), Drug Facts Labeling, formulation concerns, quality assurance/GMP challenges, and safety surveillance. We will be happy to answer any questions you may have.