Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 64

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 64
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23 $4.1B                Phase III                                Therapeutic for gastroenteropancreatic neuroendocrine tumors                                                                                                                                              Ac225 Dotatate for neuroendocrine tumors, targeting different molecule  
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Regulatory Authorities

The ongoing research and development,
clinical, regulatory, commercial and manufacturing activities of our drug candidates are subject to extensive regulation by numerous governmental
authorities, including (i) in Australia, principally the Therapeutics Goods Administration, or TGA; (ii) in the United States,
principally the Food and Drug Administration, or FDA; and (iii) in Europe, principally the European Medicines Agency, or EMA and
local competent authorities, ethics committees (ECs), institutional research boards (IRBs) and other regulatory authorities at federal,
state or local levels. We, along with our third-party contractors, will be required to navigate the various preclinical, clinical and
commercial approval and post-approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies
or seek approval or licensure of our drug candidates.

United States

FDA process

In the United States, the
FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations. Regulations that govern
the pharmaceutical quality, safety, efficacy, labeling, storage, record keeping, advertising and promotion of such products under the
Federal Food, Drug and Cosmetic Act, the Public Health Service Act, and their implementing regulations.

The process of obtaining FDA
approval and achieving and maintaining compliance with applicable laws and regulations requires the expenditure of substantial time and
financial resources. Failure to comply with applicable FDA or other requirements may result in refusal to approve pending applications,
a clinical hold, warning letters, civil or criminal penalties, recall or seizure of products, partial or total suspension of production
or withdrawal of the product from the market. FDA approval is required before any new drug or biologic, including a new use of a previously
approved drug, can be marketed in the United States. All applications for FDA approval must contain, among other things, information relating
to safety and efficacy, pharmaceutical quality, packaging, labeling and quality control.

Government oversight of the
pharmaceutical industry is usually classified into pre-approval and post-approval