Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 191

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 191
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the FDA’s advertising and promotion requirements, such as those related to direct-to-consumer advertising, the prohibition on promoting
products for uses or inpatient populations that are not described in the product’s approved labeling (known as “off-label
use”), industry-sponsored scientific and educational activities, and promotional activities involving the internet. Discovery of
previously unknown problems or the failure to comply with the applicable regulatory requirements may result in restrictions on the marketing
of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions. Failure to comply with the
applicable U.S. requirements at any time during the product development process, approval process, or after approval may subject
an applicant or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity. FDA sanctions could include
refusal to approve pending applications, withdrawal of an approval or license revocation, clinical hold, warning or untitled letters,
product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government
contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil
or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect.

Biological product manufacturers
and other entities involved in the manufacture and distribution of approved biological products are required to register their establishments
with the FDA and certain state agencies, and they are subject to periodic unannounced inspections by the FDA and certain state agencies
for compliance with cGMPs and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the areas of
production and quality control to maintain cGMP compliance. Manufacturers and other parties involved in the drug supply chain for prescription
drug products must also comply with product tracking and tracing requirements and for notifying the FDA of counterfeit, diverted, stolen
and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. Discovery of
problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including
withdrawal of the product from the market. In addition, changes to the manufacturing process or facility generally require prior 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 FDA review and approval.

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Orphan Drug Designation

Under the Orphan Drug Act,