U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
Choosing a Regulatory Pathway for Your Drug
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NDA Deviation

Although the focus of this course is to foster a better understanding and assist interested parties in bringing an OTC drug to market under the OTC monograph system, it is always the responsibility of any party marketing an OTC drug to ensure the drug is being legally marketed.

Having completed a review of the course materials, you may determine you cannot legally market your drug in the absence of an application.

For example, if your product's formulation, labeling, dosage form, and/or indications for use do not conform to an applicable OTC drug monograph, and you have elected not to pursue or have not been successful in pursuing either the CP or TEA processes described earlier, you will likely need to submit and obtain FDA approval of an NDA to legally market the product in the United States.

Larry

Mattie with a text box: What if I determine that I cannot legally market my new drug without an application? What should I do?
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Click the picture of Larry to learn more. Click NEXT to continue.
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