#4: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans

January 24, 2017

On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry.” This revision addresses several public comments submitted by Industry on the original 2013 draft guidance of the same name.

In 2003, the Pediatric Research Equity Act (PREA) was made law. This required sponsors of particular drugs to conduct studies in pediatric populations; however, the timing and details of a pediatric plan were not established. In 2012, Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted, requiring Sponsors to submit Pediatric Study Plans (PSPs) to the Agency outlining what pediatric studies they plan to conduct, or a rationale for deferrals or waivers from those studies.

The FDA’s first PSP draft guidance set the Agency’s current thinking and provided a structure for submission and review of initial PSPs (iPSPs). The revised draft guidance retained most of these characteristics including:

  • Who must submit an iPSP;
  • When an iPSP should be submitted;
  • What is included in an iPSP; and
  • A template for iPSP submissions.

Furthermore, the revised draft guidance also added the followed:

  • Clarity on material incomplete iPSPs;
  • Contents and timing of amendments to an iPSP; and
  • Clarity on non-agreed iPSPs.

The comment period for the revised draft guidance ended on May 9, 2016.  During the time it was open, various parties submitted six comments requesting alterations or clarity on limited topics. One of the main topics discussed in these comments was FDA feedback during Agency review. Sponsors specifically requested clarity regarding whether or not discussion with FDA would occur during the second 90-day iPSP review period. Additionally, Sponsors poised questions concerning meetings with FDA when disagreements or non-agreed PSPs occur. Harmonization with the European Union’s Paediatric Investigation Plan (PIP) was also a common concern raised by Sponsors.

Industry comments have given the FDA several areas to review and work to improve the PSP revised draft guidance. ProPharma Group will continue to monitor for updates in the current PSP draft guidance as well as the FDA’s current thinking on other relevant industry issues. If your company needs assistance putting together a PSP or other FDA submissions, ProPharma Group can help.  To learn more about our qualifications and capabilities, contact us today.


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