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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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The process for obtaining single-patient expanded access (EA) has several steps and documents to organize. This checklist offers a brief overview of the documents a licensed physician must fill out or obtain from the...
In October 2017, FDA released a six-page, Information Sheet Guidance for sponsors, clinical investigators and IRBs on the Waiver of IRB requirements for Drug and Biological Product Studies.
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