Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 218

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 218
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 receive the FDA approval would be subject to continuing
regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product,
providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain
electronic records and signature requirements and complying with the FDA promotion and advertising requirements. In addition, the FDA
may require post-approval studies, including Phase 4 clinical trials, to further assess a product’s safety and effectiveness after
NDA approval and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.
The FDA also may conclude that an NDA may only be approved with a Risk Evaluation and Mitigation Strategy designed to mitigate risks through,
for example, a medication guide, physician communication plan, or other elements to assure safe use, such as restricted distribution methods,
patient registries and other risk minimization tools.

Post-Approval Requirements

Any products for which we
receive the FDA approval are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements,
reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and
distribution requirements, complying with certain electronic records and signature requirements and complying with the FDA promotion and
advertising requirements. The FDA strictly regulates labeling, advertising, promotion and other types of information on products that
are placed on the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved
label. Further, manufacturers must continue to comply with cGMP requirements, which are extensive and require considerable time, resources
and ongoing investment to ensure compliance. In addition, changes to the manufacturing process generally require prior the FDA approval
before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims,
are also subject to further the FDA review and approval.

The FDA may withdraw a product
approval if compliance with regulatory requirements is not maintained or if problems occur after the product reaches the market. Later
discovery of previously unknown problems with a product may result in restrictions on the product’s marketing or even complete withdrawal
of the product from the market. Further, the failure to maintain compliance with regulatory requirements may result in administrative
or judicial actions, such as fines, untitled or warning letters, holds on clinical trials, product seizures, product detention or refusal
to permit the import or export of products, refusal to approve pending applications or supplements,