United States. Department of Health and Human Services. issuing body.
United States. Food and Drug Administration. issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Silver Spring, MD : Center for Drug Evaluation and Research, July 2020
The purpose of this guidance is to provide recommendations to sponsors regarding the submission of an initial pediatric study plan (iPSP) and any amendments to the iPSP. Specifically, this guidance provides the current thinking of the Food and Drug Administration (FDA) regarding implementation of the requirement for sponsors to submit an iPSP, described in section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance addresses the following: (1) Applications for which an iPSP is required; (2) Timing of an iPSP submission; (3) Content of an iPSP; (4) Content and timing of a requested amendment to an agreed iPSP; (5) A template that is recommend to be used for an iPSP submission.
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