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USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"

Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment".

The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in developing drugs to prevent or treat acute radiation syndrome (ARS) resulting from accidental or deliberate exposure to ionizing radiation.

In general, drugs intended for such indications must be approved under regulations known as the Animal Rule. ARS is the term applied to a variety of clinical manifestations resulting from the exposure of humans to high doses of radiation.

In situations where the efficacy of the product cannot be directly demonstrated in humans, the Animal Rule permits the use of animal data with human data to support the approval of medical products for use in humans. However, it is important to note that under the Animal Rule, human studies are still required to demonstrate a drug’s safety.

ARS drugs may qualify for certain FDA expedited programs (e.g., fast track and priority review) or other FDA designations (e.g., orphan drug designation). Sponsors requesting these designations should follow established processes.

To know in detail about the Drug Development Plan, CMC, Requirement for Postmarketing Evaluation, etc click this LINK.


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