Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 15, 2019
April 24, 2020
e5cdf45b-9688-49a6-8496-614c702750aa
Related Documents
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry
Guidance DocumentAugust 2, 2019Center for Drug Evaluation and Research
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry: Guidance for Industry
Guidance DocumentAugust 15, 2019Center for Drug Evaluation and Research
Testicular Toxicity: Evaluation During Drug Development
Guidance DocumentOctober 25, 2018Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox