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# Guide on Nonclinical Development for Hematologic Disorders
- URL: https://www.fdaweb.com/guide-on-nonclinical-development-for-hematologic-disorders/
- Published: 2018-04-24T12:00:00.000Z
- Updated: 2026-09-15T00:00:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141287

*Federal Register* notice: FDA has made available a draft guidance entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” The document is intended to provide information to assist sponsors in designing appropriate nonclinical studies for developing such products. It also discusses a streamlined approach to drug development to allow patients with these conditions access to new and potentially effective therapies. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-04-24/pdf/2018-08548.pdf?ref=fdaweb.com).