Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 123

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 123
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 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 penalties brought by the FDA or the Department
of Justice (“DOJ”), and other governmental entities, including state agencies.

Preclinical Studies and Investigational New Drug Application

Once a therapeutic product candidate is identified
for development, it must undergo preclinical studies (also known as preclinical testing) before any testing may be conducted in humans.
Preclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate the
potential for efficacy and toxicity in animals. The conduct of preclinical tests and formulation of the compounds for testing must comply
with federal regulations and requirements, including GLPs. The results of the preclinical tests, together with manufacturing information,
analytical data, and plans for the proposed clinical studies, are submitted to the FDA as part of an IND. Some preclinical testing may
continue after an IND is submitted.