Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 396

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 396
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 data integrity requirements to assure that the facilities, methods and controls are adequate to preserve 
 the drug or biologic’s identity, safety, efficacy, quality, purity and/or potency, and, in the case of cell-based advanced therapy,       
 to assure compliance with current Good Tissue Practices;                                                                                  |

| ● | satisfactory                                                                                                                       
 completion of FDA audits of selected clinical investigation sites to assure compliance with cGCP requirements and the integrity of 
 the clinical data;                                                                                                                 |

| ● | payment                                                                          
 of user fees under the Prescription Drug User Fee Act for the relevant year; and |

| ● | compliance                                                                                                                               
 with post-approval requirements, including the potential requirements to implement a Risk Evaluation and Mitigation Strategy, or “REMS”, 
 adverse event and biological product deviation reporting and to complete any post-approval studies.                                      |

The testing and approval process typically requires many years and substantial effort and financial resources, and the receipt and timing of any approval is uncertain. The actual time required may vary substantially based upon the type, complexity, and novelty of the product or disease.

| 214 |

Preclinical and Clinical Trials in Support of an NDA or BLA

Before an applicant can begin testing the potential candidate in human subjects, the applicant must first conduct preclinical studies. Preclinical studies generally include laboratory evaluations of product chemistry, formulation, and toxicity, as well as in vitroand animal studies to assess the potential safety and bioactivity of the product candidate for initial testing in humans and to establish a rationale for therapeutic use. Preclinical trials are subject to federal regulations and requirements, including GLP regulations. The results of the preclinical studies, together with manufacturing information and analytical data, among other things, are submitted to the FDA as part of an IND, which must become effective before clinical trials may be commenced.

An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. An IND is an exemption from the FDCA that allows an unapproved drug product to be shipped in interstate commerce for use in an investigational clinical trial. Such authorization must be secured prior to interstate shipment and administration of a drug or biologic that is not the subject of an approved NDA or BLA. In support of a request for an IND, applicants must submit a protocol for each clinical trial. Any subsequent protocol amendments must be submitted to the FDA as part of the IND. The IND will become effective automatically 30 days after receipt by the FDA, unless the FDA raises safety concerns or questions about the conduct