Federal Register Notice: FDA is making available a draft guidance entitled Guidance for Industry; Process for Handling Pediatric Referrals to FDA: Additional Safeguards for Children in Clinical Investigations. This document is intended to assist clinical investigators, institutional review boards, sponsors, and other interested parties in understanding the agency’s process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under FDA regulations on additional safeguards for children in clinical investigations. To download the draft, click here. To view this notice, click here.