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What if a sponsor does not comply with an FDA requirement to perform a pediatric assessment within the set time?

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What if a sponsor does not comply with an FDA requirement to perform a pediatric assessment within the set time?

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A20. If an applicant does not conduct a required pediatric assessment within the set time, the reviewing division should first notify and meet with the applicant to discuss the reasons for non submission of the studies within the agreed timeframe.

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