Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3435

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3435
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posed REMS. The FDA will not approve the NDA or BLA without an approved REMS, if required. A REMS could include medication guides,
physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk
minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription
or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following
initial marketing.

FDA
regulations require that products be manufactured in specific approved facilities and in accordance with cGMP regulations. We rely, and
expect to continue to rely, on third parties for the production of clinical and commercial quantities of our products in accordance with
cGMP regulations. These manufacturers must comply with cGMP regulations that require, among other things, quality control and quality
assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers
and other entities involved in the manufacture and distribution of approved drugs or biologics are required to register their establishments
with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area
of production and quality control to maintain cGMP compliance. The discovery of violative conditions, including failure to conform to
cGMP regulations, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions
on a product, manufacturer or holder of an approved NDA or BLA, including recall.

Once
an approval is granted, the FDA may issue enforcement letters or withdraw the approval of the product if compliance with regulatory requirements
and standards is not maintained or if problems occur after the drug or biologic reaches the market. Corrective action could delay drug
or biologic distribution and require significant time and financial expenditures. Later discovery of previously unknown problems with
a drug or biologic, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply
with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market
studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other
potential consequences include, among other things:

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