Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 181

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 181
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S as a condition of approval to ensure that the benefits
of the product outweigh its risks and to assure its safe use. REMS use risk minimization strategies beyond the professional labeling to
ensure that the benefits of the product outweigh the potential risks. To determine whether a REMS is needed, the FDA will consider the
size of the population likely to use the product, seriousness of the disease, expected benefit of the product, expected duration of treatment,
seriousness of known or potential adverse events, and whether the product is a new molecular entity. REMS can include medication guides,
physician communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU may include, but are not
limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring,
and the use of patient registries. The FDA may require a REMS before 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