Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3434

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3434
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 can submit amendments
to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical
studies, early phase clinical trials and/or other clinical development programs. Unless otherwise required by regulation, PREA generally
does not apply to a drug or biologic for an indication for which orphan designation has been granted.

A
drug or biologic product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six
months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection
or patent term, may be granted if a sponsor submits pediatric data that fairly responds to a “Written Request” from the FDA
for such data. The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical
trial is deemed to fairly respond to the FDA’s request, the additional protection is granted.

Post-Approval
Requirements

Following
approval of a new product, the manufacturer and the approved product are subject to continuing regulation by the FDA, including, among
other things, monitoring and record-keeping activities, reporting of adverse experiences, complying with promotion and advertising requirements,
which include limitations on industry-sponsored scientific and educational activities and restrictions on promoting products for unapproved
uses or patient populations (known as “off-label use”). Although physicians may in their independent medical judgment prescribe
legally available products for off-label uses, manufacturers may not market or promote such uses. The FDA and other agencies actively
enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted
off-label uses may be subject to significant liability, including investigation by federal and state authorities. Prescription drug promotional
materials must be submitted to the FDA in conjunction with their first use or first publication.

53

Further,
if there are any modifications to the drug or biologic, including changes in indications, labeling or manufacturing processes or facilities,
the applicant may be required to submit and obtain FDA approval of a new NDA/BLA or NDA/BLA supplement, which may require the development
of additional data or preclinical studies and clinical trials. The FDA may also place other conditions on approvals including the requirement
for a REMS, to assure the safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the NDA or BLA must submit a
pro