Providing Over-the-Counter Monograph Submissions in Electronic Format July 2024

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-over-counter-monograph-submissions-electronic-format?utm_medium=email&utm_source=govdelivery FDA issued a final guidance for industry titled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” The final guidance provides information on providing electronic submissions to FDA under section 505G of the Federal Food, Drug, and Cosmetic Act. These electronic submissions are referred to as over-the-counter (OTC) monograph submissions. The final guidance is intended to assist submitters by describing the electronic OTC monograph submission requirements and providing recommendations and other information on how to send OTC monograph submissions to FDA in electronic format. OTC monograph submissions must be submitted electronically, and, depending on the type of submission, should be submitted to FDA through the CDER NextGen Portal, or as specified by the instructions in the OTC Monographs@FDA portal. Submissions related to updating drug listing information should be electronically submitted consistent with the Electronic Drug Registration and Listing System process and instructions. Changes from the draft guidance to the final guidance are primarily intended to clarify how to submit OTC monograph submissions through the CDER NextGen Portal. In addition, editorial changes were made to improve clarity.