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Access Whitepaper

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Investigational Drugs Outside of Clinical Trials - Understanding Expanded Access and Right-to-Try

Expanded access, the system through which the FDA provides access to investigational drugs outside of clinical trials, was designed for patients who have no known effective treatment options for serious diseases or conditions. There is a delicate balance between helping desperately ill people access treatments that could be potentially beneficial in a timely manner and ensuring that the benefits of the treatments outweigh the risks to the patient.
 
In addition to the expanded access program, legislative actions have been passed at both the federal and state level, including "right-to-try" laws and the 21st Century Cures Act, which help provide access to investigational drugs without needing to go through the FDA process. 

Read this whitepaper to learn more about expanded access and right-to-try and the complexity of giving patients access to investigational drugs.
 

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A Discussion of the Revised Common Rule - Jan 2017
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The 21st Century Cures Act: Implications for Human Subjects
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