Business · 22/12/2006

FDA Releases Guidance on Referrals of Clinical Investigations Involving Children

The Food and Drug Administration (FDA) has released a guidance document to help clinical investigators, Institutional Review Boards, and sponsors navigate the process of referring clinical investigations involving children to the FDA for review under specific regulations. The guidance finalizes a draft document from 2006 and outlines the procedures the FDA intends to follow in handling such referrals.