FDA Offers Formatting and Content Guidelines for OMORs in Draft Guidance

In a new draft guidance, the FDA offered advice on the format and content of an over-the-counter (OTC) monograph order request (OMOR) — which allows an OTC drug covered by a monograph to be marketed without an approved drug application.

Sponsors submit an OMOR to request that the agency issue a final order on whether a drug already is generally recognized as safe and effective (GRASE) or whether a change to the use of a drug is GRASE.

OMOR requirements include mandatory electronic submission for five modules — administrative information, summaries, quality, nonclinical study reports and clinical study reports.

Requestors can request a formal meeting with FDA to discuss specific data, studies, and related information to be submitted in the OMORs, the agency said.

Comments on this draft guidance are due by June 12.

Read the guidance here.

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