Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 70

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 70
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, standards for direct-to-consumer advertising, promoting products for uses or in patient populations that
are not described in the product’s approved labelling (known as “off-label use”), industry-sponsored scientific and
educational activities, and promotional activities involving the Internet. Failure to comply with FDA requirements can have negative consequences,
including adverse publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors and civil
or criminal penalties. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote
such off-label uses.

Changes to some of the conditions
established in an approved application, including changes in indications, labelling, or manufacturing processes or facilities, require
submission and FDA approval of a new BLA or BLA supplement before the change can be implemented. A BLA supplement for a new indication
typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing
BLA supplements as it does in reviewing BLAs.

Adverse event reporting and
submission of periodic reports is required following FDA approval of a BLA. The FDA also may require post-marketing testing, known as
Phase IV testing, risk mitigation strategies, and surveillance to monitor the effects of an approved product or place conditions on an
approval that could restrict the distribution or use of the product.

Foreign Regulation

In addition to regulations
in the United States, we are subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution
of our drug candidates. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory
authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process
varies from country to country and the time may be longer or shorter than that required for FDA approval. The requirements governing the
conduct of clinical trials vary greatly from country to country.

European Union and United Kingdom

In the European Economic Area,
or EEA, which is comprised of the Member States of the European Union plus Norway, Iceland and Liechtenstein, medicinal products can only
be commercialized after obtaining a Marketing Authorization, or MA by the EMA. Under European Union regulatory systems, we must submit
and obtain authorization for a clinical trial application in each member state in which we intend to conduct a clinical trial. When conducting
clinical trials in the European Union, we must adhere to the provisions of the European Union Clinical Trials Directive (Directive 2001