Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 128

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 128
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 the FDA begins an in-depth
review of the application. Under the goals and policies agreed to by the FDA under PDUFA, the FDA has ten months from the filing
date in which to complete its initial review of a standard application and respond to the applicant, and six months for a priority
review of the application. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs and the review process may
be significantly extended by FDA requests for additional information or clarification.

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During its review of a NDA, the FDA may refer
applications for novel pharmaceutical products that present difficult questions of safety or efficacy to an advisory committee. Typically,
an advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and
provides a recommendation as to whether the application should be approved and under what conditions, if any. The FDA is not bound by
the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

On the basis of the FDA’s evaluation
of the application and accompanying information, including the results of the inspection of the manufacturing facilities and any FDA
audits of preclinical and clinical trial sites to assure compliance with GLPs or GCPs, the FDA may approve the NDA or issue a complete
response letter. A complete response letter may require additional clinical data and/or other significant and time-consuming requirements
related to clinical trials, preclinical studies or manufacturing. Sponsors that receive a complete response letter have one year to submit
information that represents a complete response to the deficiencies identified by the FDA. The FDA will then 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