Pediatric Study Plans A High Level View

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Presentation transcript:

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

History of FDA Initiatives to Foster Pediatric Drug Development 1979 - Labeling Requirement 1994 - Final Rule: Pediatric labeling-extrapolation of efficacy 1997 - FDAMA/Pediatric Exclusivity Provision 1998 - Final Rule: Pediatric Studies Required 2001 - Subpart D: Additional Safeguards for Children in Clinical Investigations of FDA-regulated products

History of FDA Initiatives to Foster Pediatric Drug Development (cont) 2002 - Best Pharmaceuticals for Children Act 2003 - Pediatric Research Equity Act 2007 - Both Reauthorized under FDAAA 2012 - Both Made Permanent under FDASIA

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

Timeline for Submission of Pediatric Study Plans

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

What is Expected in the Pediatric Study Plan (PSP)

What is Expected in the PSP (cont)

What is Expected in the Pediatric Study Plan (cont)

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