Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 28, 2019
April 11, 2024
b745efcc-5e41-4458-a1d9-6827d55dd3a7
Related Documents
Pediatric HIV Infection: Drug Development for Treatment
Guidance DocumentMarch 20, 2019Center for Drug Evaluation and Research
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products: Guidance for Industry
Guidance DocumentMarch 15, 2019Center for Drug Evaluation and Research
Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway
Guidance DocumentFebruary 4, 2019Center 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