Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 183

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 183
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 approval or post-approval if it becomes aware of a serious risk associated
with use of the product. If the FDA concludes a REMS is needed as a condition of approval, the sponsor must submit a proposed REMS during
the application review process; the FDA will not approve the NDA without an approved REMS, if required. The requirement for a REMS can
materially affect the potential market and profitability of a product. After approval, many types of changes to the approved product,
such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and
FDA review and approval.

Post-Approval Requirements

Drugs or biologics manufactured
or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things,
requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting
of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other
labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fee requirements for any marketed
products, as well as new application fees for supplemental applications with clinical data.

In addition, drug and biologic
manufacturers and other entities involved in the manufacture and distribution of approved drugs or biologics are required to register
their establishments with the FDA and state agencies, and are subject to periodic prescheduled or unannounced inspections by the FDA and
the relevant state agencies for compliance with cGMP and other regulatory requirements. Changes to the manufacturing process are strictly
regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of
any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the
sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality
control to maintain cGMP compliance.

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Once an approval is granted,
the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after
the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated
severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to
the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks;
or imposition of distribution or other