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
Regulation Overview
Differences: NDA Process and OTC Monograph Process

Now that we have reviewed the NDA process and discussed the OTC Monograph Process, let's briefly review the main differences between the two pathways.

NDA Approval process

OTC Monograph Process

Pre-market approval  FDA review and approves formulation and labeling prior to marketing. No pre-market approval  FDA sets forth specific conditions for GRASE, or in the case of a developing monograph, sets forth conditions that allow for continued marketing pending a final monograph. Oversight occurs on a post-marketing basis.
Confidential filing Public process
Drug-product specific Active ingredient-specific and evaluated by OTC drug category
May require a user fee No user fees
Potential for marketing exclusivity No marketing exclusivity
FDA review timelines Manufacturers responsible for ensuring compliant product with no FDA-mandated review (either pre- or post-market)
May require clinical studies, including studies on label compprehension and actual use Generally does not require clinical studies. Label comprehension and actual use studies are not required for ingredients already covered by a final or tentative final monograph.
Approved labeling is unique to the drug Labeling is defined by the monograph. Once marketed, FDA can review the complete labeling at any time to determine whether it is truthful or misleading.
Approved NDA is your "license" to market Final monograph is open to anyone
Trade name reviewed prior to marketing No review of trade name prior to marketing. Once marketed, FDA can review the trade name at any time.

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