Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 129

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 129
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 authorization to initiate human clinical trials. The IND must include  
 preclinical data, manufacturing information, and a proposed clinical trial protocol. The IND must become effective (30-day FDA review 
 period) before human studies may commence.                                                                                            |

| ● | Institutional                                                                                                                       
 Review Board (IRB) Approval: Obtain approval from an IRB for each clinical trial site before enrolling participants in any clinical 
 study.                                                                                                                              |

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| ● | Clinical                                                                                                                               
 Trials: Conduct a series of well-controlled human clinical trials, in accordance with current Good Clinical Practice (cGCP) standards, 
 to demonstrate the safety and efficacy of the product for each intended indication.                                                    |

| ● | New Drug                                                                                                                              
 Application (NDA): Prepare and submit an NDA to the FDA, providing comprehensive data from preclinical and clinical studies, detailed 
 manufacturing and quality control information, and proposed product labeling.                                                         |

| ● | FDA Inspections:                                                                                                                       
 Undergo one or more inspections by the FDA of clinical trial sites, testing facilities, and manufacturing sites (including third-party 
 contractors), to confirm compliance with cGMP, GLP, and cGCP standards, and to ensure data integrity and product quality.              |

| ● | User Fee                                                                                                         
 Payment: Pay applicable user fees under the Prescription Drug User Fee Act (PDUFA), unless an exemption applies. |

| ● | FDA Review                                                                                                                          
 and Approval: The FDA reviews the NDA and may convene an advisory committee for input. Approval is granted if the FDA determines    
 that the product is safe and effective for its intended use, and that the manufacturing process ensures consistent product quality. |

| ● | Post-Approval                                                                                                                                
 Commitments: If approved, the sponsor must comply with post-marketing requirements, which may include Risk Evaluation and Mitigation         
 Strategies (REMS), Phase 4 (post-marketing) studies, periodic safety reporting, and continued compliance with cGMP and labeling regulations. |

Failure to comply with the applicable requirements
at any time during the product development process, including preclinical testing, clinical testing, the approval process, or post-approval
process, may subject an applicant to delays in the conduct of the study or regulatory review and approval, as well as administrative
or judicial sanctions or other consequences. These sanctions or consequences may include, but are not limited to, the FDA’s refusal
to allow an applicant to proceed with clinical testing, issuance of clinical holds for planned