Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 400

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 400
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 requesting approval to market the product for one or more indications. The cost of preparing and submitting an NDA or BLA is substantial. The application must also be accompanied by a significant user fee payment, which typically increases annually, although waivers may be granted in limited cases. Under an approved NDA or BLA, the applicant is also subject to an annual program fee.

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The FDA will initially review the NDA or BLA for completeness before accepting it for filing and the FDA has 60 days from its receipt of an NDA or BLA to determine whether the application will be accepted for filing based on the Agency’s determination that it is adequately organized and sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has substantial discretion and may refuse to file an application and request additional information, in which case the application must be resubmitted with the requested information and review of the application delayed.

With certain exceptions, NDAs and BLAs must include a pediatric assessment, generally based on clinical trial data, of the safety and effectiveness of the drug or biologic in relevant pediatric populations. Under certain circumstances, the FDA may waive or defer the requirement for a pediatric assessment, either at the sponsor’s request or by the agency’s initiative.

Once an NDA or BLA has been accepted for filing, the FDA sets a user fee goal date that informs the applicant of the specific date by which the FDA intends to complete its review. The FDA has agreed to certain performance goals to complete the review of NDAs or BLAs. This is typically ten months from the date that the FDA accepts the NDA or BLA for filing for standard review NDAs and BLAs. Applications classified as Priority Review have a performance goal of six months from the date the FDA accepts the NDA or BLA for filing. An NDA or BLA may be eligible for Priority Review if the FDA determines the drug or biological product is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness compared to available therapies. The review process can be extended by FDA requests for additional information or clarification. The FDA reviews NDAs and BLAs to determine, among other things, whether the proposed product is safe, effective, pure and/or potent for its intended

use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity. The FDA may also refer applications for novel drug or