Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 138

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 138
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 re-review the application, taking into
consideration the response, and determine whether the application meets the criteria for approval. Failure to respond to a complete response
letter will serve as a withdrawal of an application. The FDA will not approve an application until issues identified in any complete response
letters have been addressed.

If the FDA approves a new product, it may limit
the approved indication(s) for use of the product. It may also require that contraindications, warnings, or precautions be included in
the product labeling. In addition, the FDA may require post-approval studies, including Phase 4 clinical trials, to further assess
the product’s efficacy and/or safety after approval. The agency may also require testing and surveillance programs to monitor the
product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms.
The FDA may prevent or limit further marketing of a product based on the results of post-market studies or surveillance programs.

After approval, if there are any modifications
to the approved product, including changes in the indications, dosage forms, labeling, or manufacturing processes or facilities, the sponsor
may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require the generation of additional data
or the conduct of additional preclinical studies and clinical trials.

Post-Approval Regulation

Upon FDA approval of a NDA, the sponsor is
required to comply with all applicable post-approval regulatory requirements for pharmaceutical products, including any specific conditions
imposed by the FDA as part of the approval for the product or its indicated use. The sponsor will be required to report certain adverse
reactions and production problems to the FDA, provide updated safety and efficacy information, obtain FDA approval for certain manufacturing
and labeling changes, and comply with requirements concerning advertising and promotional labeling, record-keeping, and drug supply chain
security. Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state
agencies and are subject to periodic unannounced inspections for compliance with ongoing regulatory requirements, including cGMPs. Accordingly,
the sponsor and its third-party manufacturers must continue to expend time, money and effort in the areas of production and quality control,
as well as pharmacovigilance activities, to maintain compliance with cGMPs and other regulatory requirements.

Post NDA regulations include, among other things,
standards and regulations for direct-to-consumer advertising, communications regarding unapproved uses, industry-sponsored scientific
and educational activities and promotional