Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 65

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 65
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 categories. Most of the therapeutically significant
innovative products marketed today are the subject of New Drug Applications, or NDAs, or Biologics License Applications, or BLAs. Pre-approval
activities are used to assure the product is safe and effective before marketing.

Drug Approval Process - FDA

None of our drug candidates
may be marketed in the United States until the drug has received FDA approval. The steps required before a drug may be marketed in the
United States generally include the following:

  completion of extensive pre-clinical laboratory tests, animal studies, and formulation studies in accordance with the FDA’s GLP and GMP regulations;  

  submission to the FDA of an Investigational New Drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin;  
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  performance of adequate and well-controlled human clinical trials in accordance with GCP requirements to establish the safety and efficacy of the drug for each proposed indication;  

  submission to the FDA of an NDA/BLA after completion of all pivotal clinical trials;  

  satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the active pharmaceutical ingredient, or API, and finished drug product are produc...  

  FDA review and approval of the NDA/BLA prior to any commercial marketing or sale of the drug in the United States.  

After the completion of clinical
studies of a product candidate, FDA approval of a BLA must be obtained before commercial marketing of the biological product. The BLA
must include results of product development, laboratory and animal studies, human studies, information on the manufacture and composition
of the product, proposed labeling and other relevant information. In addition, under the Pediatric Research Equity Act (“ PREA”),
a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the product for the claimed indications in all
relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe
and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation,
PREA does not apply to any biological product for an indication for which orphan designation has been granted. The testing and approval
processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for