Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2539

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2539
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dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan, or PSP, within 60 days of an end-of-Phase
2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 clinical trial.
The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives
and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information,
and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric
studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor 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