Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

Our company is planning to submit a proposed pediatric study request (PPSR) to solicit a Written Request (WR) from FDA for the Phase 3 pediatric studies we plan to initiate within the next year for a non-oncology pediatric orphan indication that is exempt from PREA.

I'm struggling to find any official guidance on what content should be included in the PPSR or a template. The FDA July 2020 Guidance on Qualifying for Pediatric Exclusivity is heavily focussed on the Initial Pediatric Study Plan (iPSP) but not on the PPSR. Can anyone point me to a template or guidance on the PPSR content or would you recommend more or less following the iPSP tempate?

Can anyone share any pertinent experience / lessons learned from the PPSR process?

Your expertise is much appreciated!

To my knowledge there is not a template. I have used the structure provided by FDA for what their Written Request will include.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 12-Dec-2022 07:22
From: Anonymous Member
Subject: Proposed Pediatric Study Request (PPSR)

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

Our company is planning to submit a proposed pediatric study request (PPSR) to solicit a Written Request (WR) from FDA for the Phase 3 pediatric studies we plan to initiate within the next year for a non-oncology pediatric orphan indication that is exempt from PREA.

I'm struggling to find any official guidance on what content should be included in the PPSR or a template. The FDA July 2020 Guidance on Qualifying for Pediatric Exclusivity is heavily focussed on the Initial Pediatric Study Plan (iPSP) but not on the PPSR. Can anyone point me to a template or guidance on the PPSR content or would you recommend more or less following the iPSP tempate?

Can anyone share any pertinent experience / lessons learned from the PPSR process?

Your expertise is much appreciated!

This message was posted by a user wishing to remain anonymous

Hi Glen.
Thank you for your response. I will take your suggestion and model the PPSR content after what's in the Written Request letter template.
Kind regards!
Original Message:
Sent: 12-Dec-2022 10:39
From: Glen Park
Subject: Proposed Pediatric Study Request (PPSR)

To my knowledge there is not a template. I have used the structure provided by FDA for what their Written Request will include.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 12-Dec-2022 07:22
From: Anonymous Member
Subject: Proposed Pediatric Study Request (PPSR)

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

Our company is planning to submit a proposed pediatric study request (PPSR) to solicit a Written Request (WR) from FDA for the Phase 3 pediatric studies we plan to initiate within the next year for a non-oncology pediatric orphan indication that is exempt from PREA.

I'm struggling to find any official guidance on what content should be included in the PPSR or a template. The FDA July 2020 Guidance on Qualifying for Pediatric Exclusivity is heavily focussed on the Initial Pediatric Study Plan (iPSP) but not on the PPSR. Can anyone point me to a template or guidance on the PPSR content or would you recommend more or less following the iPSP tempate?

Can anyone share any pertinent experience / lessons learned from the PPSR process?

Your expertise is much appreciated!