Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 182

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 182
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 the manufacturing facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial
marketing of the product with specific prescribing information for specific indications. A complete response letter indicates that the
review cycle of the application is complete and the application will not be approved in its present form. A complete response letter generally
outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider
the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA or BLA,
the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type
of information included. Even with submission of this additional information, the FDA ultimately may decide that the application does
not satisfy the regulatory criteria for approval.

If the FDA approves a product,
it may limit the approved indications for use for the product, require that contraindications, warnings or precautions be included in
the product labeling, require that post-approval studies, including Phase 1V clinical trials, be conducted to further assess the drug’s
safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions,
including distribution restrictions or other risk management mechanisms, such as REMS, which can materially affect the potential market
and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-market studies
or surveillance programs. The FDA may also require an applicant to develop a REMS 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