Pediatrics
Resources
- Laws Enforced by the FDA and Related Statutes
- Office of Pediatric Therapeutics
- Pediatric Drug Development (CDER)
- FDA Amendments Act of 2007 (FDAAA): Title IV: Pediatric Research Equity Act of 2007 (PREA) and Title V: Best Pharmaceuticals for Children Act of 2007 (BPCA), September 27, 2007 (Public Law No. 110-85) (PDF)
- Establishment of the Pediatric Review Committee (PDF)
- Pediatric Research Equity Act of 2007 (PREA)
- Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials - 9/27/2007
- Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations - 5/4/2006
- Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act - 9/7/2005
- Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices - 7/24/2003
- International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population - 12/15/2000
- Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) - 12/4/2000
- Draft Guidance for Industry: Pediatric Oncology Studies In Response to a Written Request - 6/21/2000
- Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act - 10/8/1999
- Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products - 11/30/1998
- FEDERAL REGISTER Obtaining Timely Pediatric Studies of and Adequate Pediatric Labeling for Human Drugs and Biologics; Advanced Notice of Proposed Rulemaking - 4/24/2002
- FEDERAL REGISTER Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Technical Amendment; Final Rule - 10/6/2000