FDA releases long-overdue guidance on content and format of OTC drug submissions

More than a year late, the FDA today unveiled a new draft guidance document that explains how sponsors of Over-the-Counter Monograph Order Requests (OMORs) – a relatively new type of application created in 2020 – should format these applications, including the information to be provided. While the guidance may be new, the document mostly relies on long-established standards.

Regulatory Background and Context

Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs.

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