Submission & ApprovalLast reviewed April 2026

Pediatric Study Plan(PSP)

The FDA-required plan for pediatric development of a drug or biologic, submitted as part of NDA and BLA applications.

Usage Examples

The PSP was submitted after the end-of-Phase-2 meeting and agreed with FDA prior to NDA filing.
RACE Act oncology pathway required pediatric studies in relevant molecular subsets despite adult-only initial indication.

What is PSP?

The Pediatric Study Plan (PSP) is FDA's mechanism for ensuring pediatric development is addressed during drug and biologic development. Required by the FDA Safety and Innovation Act (FDASIA, 2012) and the Research to Accelerate Cures and Equity (RACE) for Children Act (2020), the PSP must be submitted no later than 60 days after the end-of-Phase-2 meeting (or earlier) and agreed with FDA.

PSP content includes: planned pediatric studies (populations, endpoints, designs, timelines), proposed pediatric formulation development, waiver or deferral requests, and anticipated indication/dosing across pediatric age groups. FDA must agree to the PSP — disagreement delays the plan and can affect NDA/BLA acceptance. RACE amendments expanded PSP requirements to oncology drugs targeting pathways also present in pediatric cancers. The US PSP is analogous to the EU Pediatric Investigation Plan (PIP), and sponsors typically align content globally.

Regulatory Context

This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside FDASIA, PREA, RACE FOR CHILDREN ACT.

FDAICHEMA

When This Matters

The PSP was submitted after the end-of-Phase-2 meeting and agreed with FDA prior to NDA filing.
RACE Act oncology pathway required pediatric studies in relevant molecular subsets despite adult-only initial indication.

Common Mistakes

Treating submission readiness as a formatting-only check without lifecycle validation.
Using outdated guidance references across modules and summaries.
Missing cross-functional review between RA, CMC, and quality before submission.

Related Regulations

FDASIAPREARACE FOR CHILDREN ACT

Frequently Asked Questions

No later than 60 days after the end-of-Phase-2 meeting, or earlier if feasible. Sponsors filing NDAs or BLAs must have an FDA-agreed PSP. Missing or disagreed PSPs can affect NDA/BLA acceptance and approval.

PSP is the US pediatric planning document; PIP is the EU equivalent. Both address pediatric development obligations but follow different procedural frameworks (FDA vs. EMA PDCO). Most global sponsors align content to minimize duplicate work while meeting each region's requirements.

Yes, through full waivers (disease doesn't occur in pediatrics), partial waivers (specific age groups), or deferrals (pediatric studies completed after initial adult approval). FDA evaluates waiver/deferral requests as part of PSP review.