Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 133

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 133
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 submit an IND safety report within 15 calendar days after the sponsor determines
that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected
adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

There are also requirements governing the reporting
of ongoing clinical trials and clinical trial results to public registries. Sponsors of certain clinical trials of FDA-regulated products
are required to register and disclose information about ongoing clinical trials, including information related to the drug, patient population,
phase of investigation, trial sites and investigators. Sponsors are also obligated to disclose theresults of completed clinical
trials, other than Phase 1 clinical trials, within specific timeframes. Information about applicable clinical trials is published
on www.ClinicalTrials.gov, a clinical trials database maintained by the National Institute of Health (NIH).

During the development of a new pharmaceutical
product, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to submission of an IND,
at the end of Phase 2, and before an NDA is submitted. Meetings at other times may be requested. 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 a New Drug Application ( 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