Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 395

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 395
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CA, and its implementing regulations, and the Public Health Service Act (“PHSA”), and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval may subject an applicant and/or sponsor to a variety of administrative or judicial sanctions, including suspension or termination of clinical trials by the FDA, imposition of a clinical hold, refusal by the FDA to approve pending or supplemental applications, withdrawal of an approval, import/export delays, issuance of warning letters and untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits or civil or criminal investigations and penalties brought by the FDA and the Department of Justice or other governmental entities. The steps required before a drug or biologic product candidate may be approved for marketing in the United States generally include:

| ● | preclinical                                                                                                            
 laboratory tests and animal studies conducted in accordance with FDA’s good laboratory practices, or GLP, regulations; |

| ● | manufacturing,                                                                 
 labeling and distribution of investigational products in compliance with cGMP; |

| ● | the                                                                                                                                    
 submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials commence and must 
 be updated annually or when significant changes are made;                                                                              |

| ● | approval                                                                                                                             
 by an independent institutional review board, or IRB, or ethics committee representing each clinical site before each clinical trial 
 may be initiated;                                                                                                                    |

| ● | adequate                                                                                                                            
 and well-controlled human clinical trials to establish the safety, efficacy, purity and/or potency of the product for each proposed 
 indication and conducted in accordance with Good Clinical Practices, or GCP;                                                        |

| ● | the                                                                                                                                   
 preparation and submission to the FDA of an NDA or BLA, after completion of all pivotal clinical trials requesting marketing approval 
 for one or more proposed indications;                                                                                                 |

| ● | FDA                                                                                                                               
 acceptance, review and approval of the NDA or BLA for specific indications, which might include an advisory committee review; and |

| ● | satisfactory                                                                                                                              
 completion of an FDA inspection of the manufacturing facility or facilities at which the product, or components thereof, are made to      
 assess compliance with cGMPs and