FDA issued a draft guidance “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment” and is requesting public comments by July 19, 2023. This draft guidance, when finalized, will provide drug developers with information and recommendations to assist in the development of drugs to prevent or treat acute radiation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 to prevent or treat ARS will require approval under the regulations commonly referred to as the Animal Rule. Developing products under the Animal Rule is very challenging, and drug developers are encouraged to establish early and ongoing communication with FDA.
Improving capabilities for addressing radiological and nuclear emergencies is a national priority. Drugs developed for ARS may be eligible for certain FDA expedited programs (e.g., fast track and priority review) or other FDA programs (e.g., orphan drug designation).
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