Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 36

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 36
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 authorizes commercial
marketing and distribution of the drug with specific prescribing information for specific indications. As a condition of NDA approval,
the FDA may require a risk evaluation and mitigation strategy (“REMS”) to help ensure that the benefits of the drug outweigh
the potential risks to patients. A REMS can include medication guides, communication plans for healthcare professionals, and elements
to assure a product’s safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification
for prescribing or dispensing the product, dispensing the product only under certain circumstances, special monitoring, and the use of
patient-specific registries. The requirement for a REMS can materially affect the potential market and profitability of the product.
Moreover, the FDA may require substantial post-approval testing and surveillance to monitor the product’s safety or efficacy.

Once
granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following
initial marketing. Changes to some of the conditions established in an approved NDA, including changes in indications, product labeling,
manufacturing processes, or facilities, require submission and FDA approval of a new NDA, or a supplement to an approved NDA, before
the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original
application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing original NDAs.

Disclosure
of Clinical Trial Information

Sponsors
of clinical trials of FDA-regulated products, including diagnostic and drugs products, are required to register and disclose certain
clinical trial information on the website www.clinicaltrials.gov. Information related to the product, patient population, phase of investigation,
trial sites, and investigators, and other aspects of a clinical trial are then made public as part of the registration. Sponsors are
also obligated to disclose the results of their clinical trials after completion. Disclosure of the results of clinical trials can be
delayed in certain circumstances for up to two years after the date of completion of the trial. Competitors may use this publicly available
information to gain knowledge regarding the progress of clinical development programs as well as clinical trial design.

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