Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 184

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 184
---
 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 Marketing Act, or PDMA, which regulates the distribution of
drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the
states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to
ensure accountability in distribution. Furthermore, the Drug Supply Chain Security Act, or DSCSA, was enacted with the aim of building
an electronic system to identify and trace certain prescription drugs distributed in the United States, including most biological products.
The DSCSA mandates phased-in and resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers
over a 10-year period, which culminated in November 2023. Most recently, the FDA announced a one-year stabilization period to November
2024, giving entities subject to the DSCSA additional time to finalize interoperable tracking systems and to ensure supply chain continuity.