Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans

Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
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.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2020
Language(s):
English
Format:
Text
Subject(s):
Clinical Studies as Topic
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (23 pages)).
NLM Unique ID:
9918227979006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227979006676