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For over-the-counter (OTC) products that are the subject of an NDA, which Office Director should sign Written Requests for pediatric studies?

April 26, 2017director NDA Office OTC over-the-counter products requests Subject written

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For over-the-counter (OTC) products that are the subject of an NDA, which Office Director should sign Written Requests for pediatric studies?

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A13. Consistent with CDER policy for decision making responsibilities on certain other regulatory documents that require Office level sign-off pertaining to OTC drug products subject to NDAs, both the Director of ODE V and the Director of the Office responsible for the specific subject matter review division should sign Written Requests for OTC products.