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Best Pharmaceuticals for Children Act

Public Law 107-109
January 4, 2002

Table of Contents

Beginning

Section 1. Short Title

Section 2. Pediatric Studies of Already-Marketed Drugs

Section 3. Research Fund for the Study of Drugs

Section 4. Written Request to Holders of Approved Applications for Drugs That Have Market Exclusivity

Section 5. Timely Labeling Changes for Drugs Granted Exclusivity; Drug Fees

Section 6. Office of Pediatric Therapeutics

Section 7. Neonates

Section 8. Sunset

Section 9. Dissemination of Pediatric Information

Section 10. Clarification of Interaction of Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act and 180-Day Exclusivity Awarded to an Applicant for Approval of a Drug Under Section 505(i) of that Act

Section 11. Prompt Approval of Drugs Under Section 505(j) When Pediatric Information is Added to Labeling

Section 12. Study Concerning Research Involving Children

Section 13. Foundation for the National Institutes of Health

Section 14. Pediatric Pharmacology Advisory Committee

Section 15. Pediatric Subcommittee of the Oncologic Drugs Advisory Committee

Section 16. Report on Pediatric Exclusivity Program

Section 17. Adverse-Event Reporting

Section 18. Minority Children and Pediatric-Exclusivity Program

Section 19. Technical and Conforming Amendments

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