Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 81

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 81
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 The comments and approvals that are
obtained are expected to lead to milestone payments under the collaborative agreement. Accordingly, our ability to navigate the regulatory
process is extremely important to the success of the Company. We believe that we have a competitive advantage in this process due to
primarily focusing on drug candidates that already have some level of success in clinical trials. Previous success of a particular candidate
in trials combined with our precision medicine approach to clinical trial design using our bfLEAP platform, will de-risk the development
process and improve the chances for success.

Government
Regulation and Product Approval

Government
authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions extensively regulate,
among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling,
advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of pharmaceutical products.
The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent
compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and
financial resources.

FDA
Approval Process

In
the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act (“FD&C
Act”) and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture,
storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling and
import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety
of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications (“NDAs”), warning or
untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil
penalties and criminal prosecution.

Pharmaceutical
product development for a new product or certain changes to an approved product in the U.S. typically involves preclinical laboratory
and animal tests, the submission to the FDA of an investigational new drug application (“IND”) which must become effective
before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the
drug for each indication for which FDA approval is sought. Satisfaction of FDA pre-market approval requirements typically takes many
years and the actual time required may vary substantially