Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 182

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 182
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 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.

| 91 |

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 restrictions under a REMS program. Other potential consequences include, among other things:

| • | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from 
 the market or product recalls;                                                                         |

| • | fines, warning letters or holds on post-approval clinical trials; |

| • | refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation 
 of product license approvals;                                                                           |

| • | product seizure or detention, or refusal to permit the import or export of products; or |

| • | injunctions or the imposition of civil or criminal penalties. |

The FDA strictly regulates
marketing, labeling, advertising and promotion of products that are placed on the market, and we must comply with the FDA’s advertising
and promotion requirements, such as those related to direct-to-consumer advertising, industry-sponsored scientific and educational activities,
and promotional activities involving the internet, as well as the prohibition on promoting products for uses or in patient populations
that are not described in the product’s approved labeling (known as “off-label use”). Drugs and biologics may be promoted
only for the approved indications and in accordance with the provisions of the approved label. 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.

In addition, the distribution
of prescription pharmaceutical products is subject to the Prescription Drug