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# Draft Guide on Hematologic Disorders Nonclinical Trials
- URL: https://www.fdaweb.com/draft-guide-on-hematologic-disorders-nonclinical-trials/
- Published: 2018-04-23T12:00:00.000Z
- Updated: 2026-09-15T00:00:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141273

FDA has released a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM605393.pdf?ref=fdaweb.com) on “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” The document is intended to assist sponsors with designing nonclinical studies for such products, particularly with avoiding unnecessary use of animals. It also discusses a streamlined nonclinical program compared to programs for products intended to treat patients with less severe diseases. Additionally, the agency notes that the guidance is intended to assist sponsors proposing non-cancer-treating products, and it does not address radiopharmaceuticals, vaccines, cellular and gene therapy products, or blood products.