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BIO Comments on FDA Draft Guidance on Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals

June 25, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.

The draft guidance is a positive step toward articulating a streamlined, science-based approach for nonclinical development of pharmaceuticals. BIO supports the FDA’s goal of getting safe, effective biopharmaceutical products to patients while avoiding the unnecessary use of animals. On the whole, BIO supports the draft guidance.

While BIO understands the draft guidance is specific to severely debilitating or life-threatening hematologic disorders (SDLTHDs), BIO believes it could be used as a model for other disease areas. In the comments, BIO provides high-level comments to strengthen and clarify areas including examples of severely debilitating or life-threatening hematologic disorders, incorporation of ICH S9 guideline, and nonclinical studies vs. nonclinical assessments.

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2018-06-25 BIO Comments On SDLTHD Nonclinical Delveopment Of Pharmaceuticals FINAL
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