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# New OTC Drug Approval Approaches
- URL: https://www.fdaweb.com/new-otc-drug-approval-approaches/
- Published: 2018-07-17T12:00:00.000Z
- Updated: 2026-09-15T00:19:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141883

FDA has published a draft guidance, *Innovative Approaches for Non-Prescription Drug Products*, with two new approaches sponsors can use to demonstrate safety and effectiveness in cases where the drug facts labeling alone is not sufficient to ensure that a drug product can be used safely and effectively in a non-prescription setting. In a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm?ref=fdaweb.com) announcing the guidance (with link to the draft), FDA commissioner **Scott Gottlieb** says some additional drugs could be available for non-prescription use if the agency can ensure access to resources that will help patients determine if the medicine is right for them.

“These approaches include applying innovative tools, like digital health technologies, that would support consumers in appropriately and safely self-selecting and using certain drugs,” he writes. One of the approaches outlined in the guidance is development of labeling in addition to the drug facts labeling, while the second approach is implementation of additional conditions so that consumers appropriately self-select and use the product.

“Either of these approaches could involve the use of technology, such as mobile apps or other tools,” Gottlieb writes. “The appropriateness and specific details of either of these approaches will depend on the circumstances that apply to a particular drug product. But it’s important we’re clear that we are not proposing a change in the evidentiary standard needed for a product to be approved by FDA as non-prescription…. The innovative approaches described in this draft guidance could lead to the approval of a wider range of non-prescription drug products, including drug products that may treat chronic conditions, in ways that maintain FDA’s gold standard for safety and effectiveness. This will require coordination and collaboration with industry and other stakeholders to strike the right balance of access while protecting public health, and we’re committed to a public process that allows for input from a broad range of voices on the impact of this proposed policy.”