Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment

19 April 2023 – the FDA published draft guidance on developing drugs for treating acute radiation syndrome. Submit comments by 19 July 2023.

The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule.

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