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Home » FDA Issues ‘Streamlined’ Trial Guidance for Hematologic Drugs
FDA Issues ‘Streamlined’ Trial Guidance for Hematologic Drugs
The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or life-threatening hematologic disorders, saying such nonclinical studies should consider general toxicology, pharmacology and reproductive toxicology.
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