Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 189

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 189
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ER-1236 and other product
candidates will also be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion,
sampling, record-keeping, and submission of safety and other post-market information. The FDA has significant post-market authority, including,
for example, the authority to require labeling changes based on new safety information and to require post-market studies or clinical
trials to evaluate serious safety risks related to the use of a biologic. Any regulatory approvals that we receive for CER-1236 or other
product candidates may also be subject to a REMS, limitations on the approved indicated uses for which the product may be marketed or
to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including post-approval clinical
trials, and surveillance to monitor the quality, safety, and efficacy of the product, all of which could lead to lower sales volume and
revenue. For example, the holder of an approved BLA is obligated to monitor and report adverse events and any failure of a product to
meet the specifications in the BLA. The holder of an approved BLA also must submit new or supplemental applications and obtain FDA approval
for certain changes to the approved product, product labeling, or manufacturing process. Advertising and promotional materials must comply
with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state laws.

In addition, product manufacturers
and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory
authorities for compliance with cGMP requirements and adherence to commitments made in the BLA or foreign marketing application. If we,
or a regulatory authority, discover(s) previously unknown problems with a product, such as adverse events of unanticipated severity or
frequency, or problems with the facility where the product is manufactured or disagrees with the promotion, marketing or labeling of that
product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or us, including requiring
recall or withdrawal of the product from the market or suspension of manufacturing.

If we or our contractors
fail to comply with applicable regulatory requirements following approval of CER-1236 or our other product candidates, a regulatory authority
may:

●issue a warning letter, untitled letter, or Form 483, asserting that we are in violation of the law;

●request voluntary product recalls;

●seek an injunction or impose administrative, civil, or criminal penalties or monetary fines;

●suspend or withdraw