Hello Sapna,
I don't know what indication your study is but many companies try to allow in their protocols to recruit paediatric patients as part of their main study with adults. This could help you to gather the data quicker and more cost-efficient than setting up a separate clinical trial. But again I don't know what type of indication this is.
Good luck with your study. It is very good to consider paediatric patients because there is a great need of treatment options for childhood diseases.
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist (Clinical trials)
Solutions OP Ltd
https://solutionsop.co.uk/United Kingdom
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Original Message:
Sent: 11-Dec-2023 04:49
From: sapna rathi
Subject: Guidance for Post marketing Pediatric study
Dear All,
For approved NDA,Can postmarketing pediatric study can be performed outside USA?
Is there any specific guidance need to follow/applicable for pediatric study performed outside USA?
Regards,
Sapna
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sapna rathi
Regulatory specialist
AHME
India
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