Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 83

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 83
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 benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug. In most
cases, the FDA requires two adequate and well-controlled Phase III clinical trials to demonstrate the efficacy of the drug. A single
Phase III trial with other confirmatory evidence may be sufficient in rare instances, such as where the study is a large multicenter
trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality,
irreversible morbidity, or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial
would be practically or ethically impossible.

After
completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before
marketing of the product may begin in the U.S. The NDA must include the results of all preclinical, clinical and other testing and a
compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls. The cost of preparing and submitting
an NDA is substantial. The submission of most NDAs is additionally subject to a substantial application user fee, and the applicant under
an approved NDA is also subject to an annual program fee for each prescription product. These fees are typically increased annually.
Sponsors of applications for drugs granted Orphan Drug Designation are exempt from these user fees.

The
FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to
an outside advisory committee – typically a panel that includes clinicians and other experts – for review, evaluation, and
a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee,
but it generally follows such recommendations.

Before
approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will
inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with
current good manufacturing practices (cGMPs) is satisfactory and the NDA contains data that provide substantial evidence that the drug
is safe and effective in the indication studied.

Fast
Track Designation

The
FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or
life-threatening disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet
medical needs for the condition. Under