Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3428

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3428
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 Act, or PDUFA, as amended, each NDA or BLA must be accompanied by a user fee. FDA adjusts the PDUFA user
fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee
for the first application filed by a small business. Additionally, no user fees are assessed on NDAs or BLAs for products designated
as orphan drugs, unless the product also includes a non-orphan indication.

50

The
FDA reviews all submitted NDAs and BLAs to ensure they are sufficiently complete to permit substantive review before it accepts them
for filing, and may request additional information rather than accepting the NDA or BLA for filing. The FDA must make a decision on accepting
an NDA or BLA for filing within 60 days of receipt, and such decision could include a refusal to file by the FDA. Once the submission
is accepted for filing, the FDA begins an in-depth review of the NDA or BLA. Under the goals and policies agreed to by the FDA under
PDUFA, the FDA targets ten months, from the filing date, in which to complete its initial review of a new molecular entity NDA or original
BLA and respond to the applicant, and six months from the filing date of a new molecular entity NDA or original BLA designated for priority
review. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs or BLAs, and the review process is often extended
by FDA requests for additional information or clarification.

Before
approving an NDA or BLA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine
whether they comply with cGMP requirements. The FDA will not approve the product unless it determines that the manufacturing processes
and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within the required
specifications. The FDA also may audit data from clinical trials to ensure compliance with GCP requirements. Additionally, the FDA may
refer applications for novel products or products which present difficult questions of safety or efficacy to an advisory committee, typically
a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should
be approved and under what conditions, if any. The FDA is not bound by recommendations of an advisory committee, but it considers such
recommendations when making decisions on approval. The FDA likely will re