FDA Draft Guidance on Pediatric Study Plans

The FDA Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, requires that the sponsor of a drug subject to the Pediatric Research Equity Act (PREA) submit an initial pediatric study plan (PSP) early in the drug development process. The intent of the PSP is to identify needed pediatric studies early in drug development and begin planning for these studies.

A draft guidance published in July 2013 specifies the timing of a PSP submission:

• The sponsor must submit the initial PSP before the submission of the required assessments and no later than 60 calendar days after the end-of-phase 2 meeting.
• In the absence of an end-of-phase 2 meeting, the sponsor should submit the initial PSP as early as practicable but before the initiation of any phase 3 studies, or any combined phase 2 and phase 3 study.
• If a phase 3 study, or a combined phase 2 and phase 3 study, will not be conducted, the sponsor should submit the initial PSP no later than 210 calendar days before the submission of a marketing application or supplement.

A sponsor should submit the initial PSP to its Investigational New Drug (IND) Application. In cases when there is no active IND for the drug, but the sponsor expects to include a phase 3 or combined phase 2 and phase 3 study, the initial PSP should be submitted as a pre-IND submission. In this situation, FDA encourages sponsors to schedule a pre-IND meeting before submission of the initial PSP.

For assistance on preparation of Pediatric Study Plans, contact RPI.