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Scroll down the resource list below to find user guides, videos, tips and helpful checklists. Some resources contain links to forms anyone can read and download but only physicians can submit. If you are looking for a specific form or topic, type it in the search bar below.

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This Q&A document from FDA outlines October 2017 updates to Guidance on Expanded Access to Investigational Drugs for Treatment Use. It covers waivers for convened IRB meetings, addresses how the FDA reviews...