Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
May 17, 2023
April 11, 2024
c7de020f-03c0-4902-a320-07443487355d
Related Documents
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations
Guidance DocumentMay 17, 2023Center for Drug Evaluation and Research
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability
Guidance DocumentOctober 31, 2022Center for Drug Evaluation and Research
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials
Guidance DocumentApril 9, 2018Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.