Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 130

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 130
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The FDA may require testing and surveillance
programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further
marketing of a product based on the results of these post-marketing programs.

The FDA may withdraw product approval if compliance
with regulatory requirements and standards is not maintained or if issues occur after the product reaches the market. Later discovery
of previously unknown issues with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes,
or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition
of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions and consequences
including:

| ● | restrictions                                                                               
 on the marketing or manufacturing of the product, including total or partial suspension of 
 production, or complete withdrawal of the product from the market;                         |

| ● | the                                                                                  
 issuance of safety alerts, Dear Healthcare Provider letters, press releases or other |

| ● | refusal                                                                                           
 of the FDA to approve pending applications or supplements to approved applications, or suspension 
 or revocation of product license approvals;                                                       |

| ● | product                                                                              
 recall, seizure or detention, or refusal to permit the import or export of products; |

| ● | imposition                                    
 of clinical holds on ongoing clinical trials; |

| ● | mandated                                                                                       
 modification of promotional materials and labeling and the issuance of corrective information; |

| ● | consent                                                                      
 decrees, corporate integrity agreements, debarment or exclusion from federal |

| ● | fines,                                                        
 injunctions or the imposition of civil or criminal penalties. |

Fast Track, Breakthrough Therapy and Priority Review Designations

The FDA has several programs intended to facilitate
and expedite development and review of new products that are intended to address an unmet medical need in the treatment of a serious
or life-threatening disease or condition. These programs are referred to as fast track designation, breakthrough therapy designation
and priority review designation. These designations are not mutually exclusive, and a product candidate may qualify for one or more of
these programs. While these programs are intended to expedite product development and approval, they do not alter the standards for FDA
approval.

The FDA may designate a product for fast track
designation if it is intended for the treatment of a serious or life-threatening disease or condition, and preclinical or clinical data
demonstrate the potential to address unmet medical needs for such a