Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 67

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 67
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, Drug and Cosmetic Act, or FDCA, and its implementing regulations, subjects pharmaceutical and other regulated medical products to rigorous premarket review as well as post-marketing oversight and potential enforcement actions. Failure to comply with applicable U.S. requirements at any time during the product development or approval process, or after approval, may subject a company to a variety of administrative or judicial sanctions brought by the FDA and the Department of Justice, or DOJ, or other governmental entities, any of which could have a material adverse effect on us. These sanctions could include: • refusal to approve pending or future marketing applications; • warning or untitled letters; • withdrawal of an approval; • imposition of a clinical hold; • voluntary product recalls; • seizures or administrative detention of product; • total or partial suspension of production or distribution; or • injunctions, fines, disgorgement, civil penalties or criminal prosecution. 32

FDA Approval Process for Prescription Drugs To obtain approval of a new drug product from the FDA, we must, among other requirements, submit extensive data supporting its safety and efficacy, as well as detailed information on the manufacture and composition of the drug and proposed product labeling and packaging. The testing and collection of data and the preparation of necessary applications are expensive and time-consuming. The FDA may not act quickly or favorably in reviewing these applications, and we may encounter significant difficulties or costs in our efforts to obtain FDA approvals that could delay or preclude us from marketing our product candidates. The process required by the FDA before a new drug may be marketed in the U.S. generally involves some or all of the following key steps: • completion of nonclinical studies, such as laboratory tests, potentially animal studies, and formulation studies, performed in compliance with FDA regulations for good laboratory practices, or GLPs, and other applicable regulations; • design of a clinical protocol and its submission to the FDA as part of an IND, which must become effective before human clinical trials may begin; • performance of adequate and well-controlled human clinical trials according to good clinical practices, or GCPs, to establish the safety and efficacy of the product candidate for its intended use; • submission of an NDA to the FDA along with payment of the application user fee and FDA acceptance of that NDA; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the active pharmaceutical ingredient, or API, and finished drug product are produced and tested to assess readiness for commercial manufacturing and conformance to the manufacturing-related elements of the application, to conduct a data integrity audit