Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 132

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 132
---
 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. |

<div align='center'>84</div>

| ● | 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 or ongoing studies, refusal to approve
pending applications, suspension or revocation of existing product licenses or approvals, issuance of warning or untitled letters, adverse
publicity, product recalls, marketing restrictions, product seizures, import detentions and refusals, total or partial suspension of manufacturing
or distribution, injunctions, fines and civil or criminal investigations and