Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 93

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 93
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 of the NDA or BLA.

After the NDA or BLA submission is accepted for
filing, the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended
use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength,
quality and purity. The FDA reviews a BLA to determine, among other things, whether the product is safe, pure and potent and the facility
in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, purity
and potency. In addition to its own review, the FDA may refer applications for novel drug or biological products or drug or biological
products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians
and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
During the approval process, the FDA also will determine whether a risk evaluation and mitigation strategy, or REMS, is necessary to assure
the safe use of the drug or biologic. If the FDA concludes that a REMS is needed, the sponsor of the NDA or BLA must submit a proposed
REMS; the FDA will not approve the NDA or BLA without a REMS, if required.

Before approving an NDA or BLA, the FDA will inspect
the facilities at which the product is to be manufactured. The FDA will not approve the product unless it determines that the manufacturing
processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required
specifications. Additionally, before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance
with cGMP. If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable it will outline
the deficiencies in the submission and often will request additional testing or information.

The NDA or BLA review and approval process is
lengthy and difficult and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require
additional clinical data or other information. Even if such data and information is submitted, the FDA may ultimately decide that the
NDA or BLA does not satisfy the criteria for approval