FDA Responds to the Challenge: The Pediatric Subcommittee

Table of Contents

1. FDA Responds to the Challenge:The Pediatric Subcommittee

2. Pediatric Subcommittee: (Pedicomm)

3. Pedicomm

4. Final Rule - 1994

5. Final Rule - 1994 (cont.)

6. Final Rule - 1994 (cont.)

7. The Pediatric Plan

8. Pedicomm/Membership

9. Pedicomm/Aiders and Abettors

10. Pedicomm Gets Started

11. Pedicomm Communication

12. Working Groups

13. Working Groups (cont.)

14. Working Groups (cont.)

15. Working Groups (cont.)

16. Important Event

17. President Clinton announces the Proposed Rule to require studies in pediatrics

18. The Proposed Rule

19. The Proposed Rule (cont.)

20. The Proposed RuleScope

21. The Proposed RuleRequired studies

22. The Proposed RuleDeferred submission

23. The Proposed RuleDeferred submissions (cont.)

24. The Proposed RuleWaivers

25. The Proposed RuleWaivers (cont.)

26. The Proposed RuleMarketed products

27. The Proposed RulePublic Meeting

28. The Proposed RuleComments

29. Pedicomm in Action Pediatric Rapid Response Team

30. Pediatric FormulationsWorking Group

31. Clinical Trials Guidance

32. Important Event

33. Modernization Act

34. Modernization Act (cont.)

35. The List

36. The ListProcess

37. The ListProcess (cont.)

38. The List Process (cont.)

39. Timeline for the List

40. Pediatric Home Page