Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 216

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 216
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 third parties, our business, financial condition, results of operations
and prospects could be materially adversely affected.

30

If
we fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization
approvals we may receive and subject us to other penalties that could materially harm our business.

Even
if we receive marketing and commercialization approval of a product candidate, there can be no assurance we will not be subject to future
or continuing regulatory review, including in relation to adverse patient experiences with the product and clinical results that are
reported after a product is made commercially available, both in the U.S. and any foreign jurisdiction in which we seek regulatory approval.
The FDA has significant post-market authority, including the authority to require labeling changes based on new safety information and
to require post-market studies or clinical trials to evaluate safety risks related to the use of a product or to require withdrawal of
the product from the market. The FDA also has the authority to require a risk evaluation and mitigation strategies (“REMS”)
plan after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug. The manufacturer
and manufacturing facilities we use to make a future product, if any, will also be subject to periodic review and inspection by the FDA
and other regulatory agencies, including for continued compliance with CGMP requirements. The discovery of any new or previously unknown
problems with our third-party manufacturers, manufacturing processes or facilities may result in restrictions on the product, manufacturer
or facility, including withdrawal of the product from the market. If we rely on third-party manufacturers, we will not have control over
compliance with applicable rules and regulations by such manufacturers. Any product promotion and advertising will also be subject to
regulatory requirements and continuing regulatory review. If we or our collaborators, manufacturers or service providers fail to comply
with applicable continuing regulatory requirements in the U.S. or foreign jurisdictions in which we seek to market our products, we or
they may be subject to, among other things, fines, warning letters, holds on clinical trials, refusal by the FDA to approve pending applications
or supplements to approved applications, suspension or withdrawal of regulatory approval, product recalls and seizures, refusal to permit
the import or export of products, operating restrictions, injunction, civil penalties and criminal prosecution.

Our
business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material
effect on our business, financial condition, results of operations or prospects.