FDA outlines Acute Radiation Syndrome drug development expectations under its Animal Rule

Today, the FDA published a new draft guidance document intended to aid developers of drugs to prevent and treat Acute Radiation Syndrome (ARS) under the Animal Rule, a regulatory program originally developed to respond to bioterrorism. The new document offers specific recommendations likely drawn from the agency’s prior approvals and describes how sponsors can leverage and crosswalk supportive human clinical data from similar conditions like oncology.

Regulatory context: The Animal Rule pathway

For a drug to be approved by the FDA, companies must demonstrate that their product is safe and effective when used as intended.

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