Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Guidance for Industry; Process for Handling Pediatric Referrals to FDA: Additional Safeguards for Children in Clinical Investigations." This guidance is intended to assist clinical investigators, institutional review boards (IRBs), sponsors, and other interested parties in understanding FDA'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. The draft guidance describes the procedures FDA generally intends to follow in handling clinical investigations referred for review under these regulations and in reaching final determinations in accordance with these regulations.