1. Pediatric Study Plans A High Level View
Daniel J. Isaacman, M.D., FAAP
Professor of Pediatrics, Drexel University School of Medicine
President, Clinical Pharma Solutsions, LLC

2. History of FDA Initiatives to Foster Pediatric Drug Development
Labeling Requirement
Final Rule: Pediatric labeling-extrapolation of efficacy
FDAMA/Pediatric Exclusivity Provision
Final Rule: Pediatric Studies Required
Subpart D: Additional Safeguards for Children in Clinical Investigations of FDA-regulated products

3. History of FDA Initiatives to Foster Pediatric Drug Development (cont)
Best Pharmaceuticals for Children Act
Pediatric Research Equity Act
Both Reauthorized under FDAAA
Both Made Permanent under FDASIA

4. Purpose of PREA (Pediatric Research and Equity Act)
Encourage sponsors to identify pediatric studies as early as possible in product development
Facilitate making pediatric data available to the public as soon as possible

5. Timeline for Submission of Pediatric Study Plans

6. How Much Detail is Required in the Initial Pediatric Study Plan?
Should provide an outline of all intended studies
General plans should be described, but full protocols not required
Protocol and statistical analysis plan must be submitted prior to initiation of each particular study in the plan
Ideally, studies should be completed before the submission of the NDA, BLA or Supplement

7. What is Expected in the Pediatric Study Plan (PSP)

8. What is Expected in the PSP (cont)

9. What is Expected in the Pediatric Study Plan (cont)

10. Assistance We Can Provide
Drafting of the PSP
Advice whether or not your given product qualifies for a Waiver from the PSP
Drafting of Waiver Request
Planning of Individual Studies
Drafting of Individual Study Protocols
Drafting of Informed Consent Forms
Recruitment of Study Investigators