Over-the-Counter Monograph Order Requests: Format and Content; Draft Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Over-the- Counter Monograph Order Requests (OMORs): Format and Content." This draft guidance provides recommendations on the format and content of the information that a requestor should provide in an over-the-counter (OTC) monograph order request (OMOR) and identifies relevant guidance documents to assist requestors in preparing their OMORs.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.