Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 186

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 186
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 FDA for marketing under the Public Health Service Act (“PHS Act”) and regulated under the Federal Food, Drug, and Cosmetic Act (“FDCA”). Both the FDCA and the PHS Act and their corresponding regulations govern, among other things, the testing, manufacturing, safety, purity, potency, efficacy, labeling, packaging, storage, recordkeeping, distribution, marketing, sales, import, export, reporting, advertising, and other promotional practices involving biological products. FDA clearance of an IND application must be obtained before commencing clinical testing of biological products. FDA licensure also must be obtained before marketing of biological products. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. U.S. Development Process The process required by the FDA before a biological product may be marketed in the United States generally involves the following:

| ● | completion of nonclinical laboratory                                                                                       
 tests and animal studies according to Good Laboratory Practices (“GLPs”) and applicable requirements for the humane use of 
 laboratory animals or other applicable regulations;                                                                        |

| ● | preparation of clinical trial      
 material in accordance with cGMPs; |

| ● | submission to the FDA of an                                                                             
 application for an IND application, which must become effective before human clinical trials may begin; |

| ● | approval by an institutional                                                                    
 review board (“IRB”), reviewing each clinical site before each clinical trial may be initiated; |

| ● | performance of adequate and                                                                                                            
 well-controlled human clinical trials according to Good Clinical Practice (“GCP”) requirements and any additional requirements         
 for the protection of human research subjects and their health information, to establish the safety, purity, potency, and efficacy, of 
 the proposed biological product for its intended use;                                                                                  |

| ● | submission to the FDA of a                                                                                                  
 Biologics License Application (“BLA”) for marketing approval that includes substantive evidence of safety, purity, potency, 
 and efficacy from results of nonclinical testing and clinical trials;                                                       |

| ● | satisfactory completion of                                                                                                              
 an FDA inspection prior to BLA approval of the manufacturing facility or facilities where the biological product is produced to assess  
 compliance with cGMPs, to assure that the facilities, methods, and controls are adequate to preserve the biologic’s identity, strength, 
 quality, and purity;                                                                                                                    |

| ● | potential FDA audit of the                                                          
 nonclinical and clinical study sites that generated the data in support of the BLA