Hi Anon
BCPA offers an extra exclusivity, more than the usual exclusivity arrangements, for certain high-priority drugs in pediatrics. Here are some links maybe useful
https://www.fda.gov/drugs/development-resources/pediatric-product-development
https://www.fda.gov/drugs/development-resources/best-pharmaceuticals-children-act-bpca
https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-two-draft-guidances-industry-support-approval-pediatric-drug-products
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Anne LeBlanc
United States
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Original Message:
Sent: 16-Jan-2024 07:33
From: Fabiola Federico
Subject: Paediatric studies in US_ incentives and rewards
Hi All,
I'm trying to collect the pediatric requirements in force in the US for a new medicinal product (small molecule), with a particular focus on incentives and rewards for sponsors.
I've consulted the FDA Guidance on initial submission of Pediatric Study Plans and subsequent amendments but, I have now found an additional guidance on pediatric exclusivity under section 505A of the Modernization Act (link: here).
My understanding is that the first guidance only applies to applications subject to PREA (i.e. mandatory PSP to be conducted for any application involving new indications or dosage forms or regimen, etc., unless a waiver is granted), while the second guidance only applies to applications subject to BPCA (voluntary PSP conducted by sponsors on the basis on a FDA written request)
Is my understanding correct? If so, is it correct to consider that pediatric exclusivity is only applicable to voluntary PSP conducted under BPCA? What incentives or rewards are available under PREA?
If possible, I 'd like to maintain the request anonymous.
Thank you in advance,
Fabiola Federico
Sn Global RA Manager
Global Regulatory Affairs
CHIESI FARMACEUTICI S.p.A.