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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.” The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-1146.