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If a sponsor submits an application on a drug for which there are multiple NDAs held by multiple sponsors, who is responsible for conducting the pediatric assessment?

April 26, 2017application conducting drug held ndas responsible sponsor sponsors submits

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If a sponsor submits an application on a drug for which there are multiple NDAs held by multiple sponsors, who is responsible for conducting the pediatric assessment?

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A29. The applicant who submitted the application is responsible for conducting a pediatric assessment. However, at present FDA would only require the applicant of the application to conduct the assessment for the drug product and indication included in the application.