Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 129

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 129
---
 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 New Drug Application
(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 activities involving the internet and social media. Promotional claims about a drug’s
safety or effectiveness are prohibited before the NDA is approved. Once a NDA is approved, the sponsor can make only those claims relating
to safety, efficacy, purity and potency that are in accordance with the provisions of the approved label. In the United States, healthcare
professionals are generally permitted to prescribe legally available drugs for uses that are not described in the product’s labeling
and that differ from those approved by the FDA. Such off-label uses are common across medical specialties. The FDA does not regulate
the practice of medicine or healthcare providers’ choice of treatments. However, FDA regulations do impose rigorous restrictions
on manufacturers’ communications of off-label uses. Additionally, promotional materials for prescription drug products must be
submitted to the FDA in conjunction with their first use.

<div align='center'>