Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 183

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 183
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 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.
From time to time, new legislation and regulations may be implemented that could significantly change the statutory provisions governing
the approval, manufacturing and marketing of products regulated by the FDA. It is impossible to predict whether further legislative or
regulatory changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact of such changes, if any,
may be.

Abbreviated New Drug Applications for Generic Drugs

In 1984, with passage of the
Hatch-Waxman amendments to the FDCA, Congress authorized the FDA to approve generic drugs that are the same as drugs previously approved
by the FDA under the NDA provisions of the statute and also enacted Section 505(b)(2) of the FDCA. To obtain approval of a generic drug,
an applicant must submit an abbreviated new drug application, or ANDA, to the agency. In support of such applications, a generic manufacturer
may rely on the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the
reference listed drug, or RLD.

Specifically, in order for
an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients, the
route of administration, the dosage form, and the strength of the drug. At the same time, the FDA must also determine that the generic
drug is “bioequivalent” to the innovator drug. Under the statute, a generic drug is bioequivalent to a RLD if “the rate
and extent of absorption of the drug do not show