Company: CERO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001213900-25-010230
Chunk: 171

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 171
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 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; |

| ● | potential                                                                                                                    
 FDA advisory committee meeting to elicit expert input on critical issues and including a vote by external committee members; |