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# CDER NextGen Portal Taking Certain OTC eSubmissions
- URL: https://www.fdaweb.com/cder-nextgen-portal-taking-certain-otc-esubmissions/
- Published: 2022-10-03T12:00:00.000Z
- Updated: 2026-09-14T18:01:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152874

FDA has expanded [CDER’s NextGen Portal](https://edm.fda.gov/?ref=fdaweb.com) to enable certain electronic over-the-counter (OTC) monograph submissions under section 505G of the Federal Food, Drug, and Cosmetic Act. “Requests for formal meetings between FDA and sponsors and requestors of OTC monograph drugs and related meeting correspondence (e.g., meeting packages) should now be submitted via the CDER NextGen Portal,” an [agency notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-expands-cder-nextgen-portal?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

FDA also says it will further develop the portal to enable sponsors and requestors to submit other OTC monograph submissions, such as OTC monograph order requests, formal dispute resolution requests related to a final administrative order, administrative hearing requests related to a final administrative order, and responses to record requests by FDA relating to minor changes.