Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 81

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 81
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 procedures to withdraw product approval if the sponsor’s confirmatory trial fails to verify the claimed
clinical benefits of the product.

All promotional materials for drug candidates being
considered and approved under the accelerated approval program are subject to prior review by the FDA.

Post-Approval Requirements

After approval, the manufacturer and the approved
drug product are subject to extensive continuing regulation by the FDA, which includes, among other things, obligations to manufacture
the product in accordance with cGMP, monitoring and recordkeeping activities, reporting of adverse experiences with the product, product
sampling and distribution restrictions, complying with FDA promotion and advertising requirements, which include restrictions on promoting
drugs for unapproved uses or patient populations (i.e., “off-label uses”) and limitations on industry-sponsored scientific
and educational activities. The manufacturer and its products are also subject to similar post-approval requirements by regulatory authorities
comparable to FDA in jurisdictions outside of the United States where the products are approved. Although physicians may prescribe legally
available products for off-label uses, manufacturers may not market or promote such uses. The FDA and other agencies actively enforce
the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label
uses may be subject to significant liability. If there are any modifications to the product, including changes in indications, labeling
or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA or a supplement
to an NDA, which may require the applicant to develop additional data or conduct additional nonclinical studies and clinical trials. The
FDA may also place other conditions on approvals including the requirement for a REMS to assure the safe use of the product. A REMS could
include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient
registries and other risk minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion,
distribution, prescription or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards
or if problems occur following initial marketing.

FDA regulations require that products be manufactured
in specific approved facilities and in accordance with cGMPs. The cGMP regulations include requirements relating to organization of personnel,
buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls,
packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products.
The manufacturing facilities