- Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans (PDF - 408 KB)
Draft Guidance for Industry
- Guidance for Industry and Review Staff: Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling
- Guidance for Industry (Draft): How to Comply with the Pediatric Research Equity Act (PDF - 116 KB)
- Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry
Find more guidances by using the search box on FDA Guidance Documents.