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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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When discussing the possible use of an investigational treatment, it is important to have all the information needed to make a decision. Here are some questions you may ask your physician to ensure you understand...
If single-patient expanded access (EA) is permitted for a patient, the sponsoring physician is required to comply with FDA reporting requirements during and after the treatment. Clinical trial outcomes are primary...
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...
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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