Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Pediatric Product Development
Published
March 30, 2023
Last updated
April 11, 2024
Description
A draft guidance document outlines the process for referring research involving children to the FDA and OHRP, focusing on pediatric product development.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)