Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 127

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 127
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 These meetings can provide an opportunity
for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA
to reach agreement on the next phase of development.

Compliance with cGMPs

Concurrent with clinical trials, companies
must finalize a process for manufacturing the product in commercial quantities in accordance with cGMPs. The manufacturing process must
be capable of consistently producing quality batches of the product and, among other things, companies must develop methods for testing
the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested and
stability studies must be conducted to demonstrate that the products do not undergo unacceptable deterioration over their shelf life.
Before approving an NDA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not
approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMPs and adequate
to assure consistent production of the product within required specifications. Material changes in manufacturing equipment, location,
or process post-approval, may result in additional regulatory review and approval.

Review and Approval of an NDA

The results of clinical trials and preclinical
studies, together with detailed information regarding the manufacturing processes, chemistry and composition of the product, the proposed
labeling and other relevant information, are submitted to the FDA as part of an NDA requesting approval to market the product for one
or more specified indications. Clinical and preclinical data may come from company-sponsored trials or from a number of alternative sources,
including studies initiated by investigators, and the NDA must include any negative and ambiguous results, as well as positive results.
To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety, purity, and potency
of the investigational product to the satisfaction of the FDA. For most NDAs, the sponsor is required to pay a substantial application
user fee at the time of submission and the sponsor of an approved NDA is subject to an annual program fee. Certain exceptions and waivers
are available for some of these fees, such as an exception from the application fee for products with orphan designation and a waiver
for certain small businesses.

The FDA has 60 days after submission
of the application to conduct an initial review to determine whether to accept it for filing based on the agency’s threshold determination
that it is sufficiently complete to permit substantive review. If the submission has been accepted for filing,