Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to Food and Drug Administration Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations

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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to FDA Under 21 CFR 50.54: 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 guidance describes the procedures FDA generally intends to follow in handling clinical investigations referred for review under Sec. 50.54 (21 CFR 50.54) and in reaching final determinations in accordance with these regulations. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2006.