New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for Comments
The Food and Drug Administration (FDA, Agency, or we) is seeking public comments on the "New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation." The purpose is to seek public comments/feedback on the Integrated Review documentation generated by the Integrated Assessment of Marketing Applications for new drug products developed as part of the New Drugs Regulatory Program Modernization. The Agency hopes to receive public feedback on how this Integrated Review documentation can continue supporting our stakeholders' needs.
Abstract as published in the Federal Register.
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