Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 35

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 35
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 Under
an approved NDA, the applicant is also subject to an annual program fee. These fees typically increase annually. The FDA has 60 days
from its receipt of an NDA to determine whether the application will be filed based on the FDA’s determination that it is adequately
organized and sufficiently complete to permit substantive review. Once the submission is filed, the FDA begins an in-depth review. The
FDA has agreed to certain performance goals to complete the review of NDAs. Most applications are classified as Standard Review products
that are reviewed within 10 months of the date the FDA files the NDA. Applications classified
as Priority Review are reviewed within six months of the date the FDA files the NDA. An NDA can be classified for Priority Review when
the FDA determines the drug has the potential to treat a serious or life-threatening condition and, if approved, would be a significant
improvement in safety or effectiveness compared to available therapies. The review process for both standard and priority reviews may
be extended by the FDA for three or more additional months to consider certain late-submitted information, or information intended to
clarify information already provided in the NDA submission.

The
FDA may also refer applications for novel products, as well as products that present difficult questions of safety or efficacy, to be
reviewed by an advisory committee – typically a panel that includes clinicians, statisticians and other experts – for review,
evaluation, and a recommendation as to whether the NDA should be approved. The FDA is not bound by the recommendation of an advisory
committee but 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 product is manufactured.
The FDA will not approve the product unless compliance with current good manufacturing practices (“cGMP”) is satisfactory.
After the FDA evaluates the NDA and completes any clinical and manufacturing site inspections, it issues either an approval letter or
a complete response letter. A complete response letter generally outlines the deficiencies in the NDA submission and may require substantial
additional testing or information in order for the FDA to reconsider the application for approval. If, or when, those deficiencies have
been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed
to reviewing such resubmissions in two or six months depending on the type of information included. An approval letter