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USFDA Guidance: Format and Content for OTC Monograph Order Requests

Earlier today (12 April 2023) USFDA's Center for Drug Evaluation and Research released a draft guidance on"Over-the-Counter Monograph Order Requests: Format and Content".

Over-the-Counter (OTC) medications are drugs that can be purchased without a prescription from a healthcare provider.

These drugs are regulated by the United States Food and Drug Administration (FDA) through the OTC Monograph system. The OTC Monograph system is a set of regulations that establish the safety, efficacy, and labeling requirements for certain OTC drug products.

This guidance is intended to assist requestors in preparing over-the-counter (OTC) monograph order requests (OMORs) for submission to FDA and provides FDA's recommendations on the format and content of the information requestors should provide in an OMOR as well as identifies relevant guidance documents to assist requestors in preparing their OMOR.

A drug manufacturer must submit an Order Request to the FDA if they wish to market an OTC product covered by a monograph. The Order Request is a formal document that outlines the manufacturer's intent to market the product and includes all of the necessary information about it.

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

OMORs should adhere to the organizational structure and format specified in the Common Technical Specification for the Registration of Medicines for Human Use, and they must be submitted electronically (CTD).

Click this LINK to know more exclusively on the Format and Content for OTC Monograph Order Requests.


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