NextGen Portal Accepts OTC Monograph Files

CDER says its NextGen Portal began accepting Over-the-Counter Monograph Order Requests (OMORs) beginning 10/1. The portal allows users to report information to FDA, including certain OTC monograph drug submissions. and submit requests for formal meetings with reviewers and materials related to such meetings. “Before submitting an OMOR, FDA recommends meeting with FDA to discuss specific data, studies, and related information to be submitted in the OMOR,” the agency says. For more information about OMORs, FDA points to the following resources:

• Draft Guidance for Industry: Over-the-Counter Monograph Order Requests: Format and Content
• Draft Guidance for Industry: Providing Over-the-Counter Monograph Submissions in Electronic Format
• Draft Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
• Webinar: OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
• OMUFA User Fee Rates