Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 84

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 84
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 the Fast Track program, the sponsor of a new drug candidate may request that the FDA designate
the drug candidate for a specific indication as a Fast Track drug concurrent with, or after, the filing of the IND for the drug candidate.
FDA must determine if the drug candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’s request.

If
a submission is granted Fast Track Designation, the sponsor may engage in more frequent interactions with the FDA, and the FDA may review
sections of the NDA before the application is complete. This rolling review is available if the applicant provides, and the FDA approves,
a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s time
period goal for reviewing an application does not begin until the last section of the NDA is submitted. While we may seek Fast Track
Designation, there is no guarantee that we will be successful in obtaining any such designation. Even if we do obtain such designation,
we may not experience a faster development process, review or approval compared to conventional FDA procedures. A Fast Track Designation
does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular timeframe.
Additionally, Fast Track Designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data
emerging in the clinical trial process.

Post-Approval
Requirements

Once
an NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval
marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored
scientific and educational activities and promotional activities involving the internet. Drugs may be marketed only for the approved
indications and in accordance with the provisions of the approved labeling.

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Adverse
event reporting and submission of periodic reports are required following FDA approval of an NDA. The FDA also may require post-marketing
testing, known as Phase IV testing, REMS and surveillance to monitor the effects of an approved product, or the FDA may place conditions
on an approval that could restrict the distribution or use of the product. In addition, quality control, drug manufacture, packaging
and labeling procedures must continue to conform to cGMPs after approval. Drug manufacturers and certain of their subcontractors are
required to register their establishments with FDA and certain state agencies. Registration with the FDA subjects entities to periodic
un