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U.S. Department of Health and Human Services

For Consumers

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Expanded Access Training Webinar

FDA and American Society for Clinical Oncology (ASCO) have collaborated to create an educational webinar to explain expanded access and clarify the process to access investigational drugs outside of a clinical trial for serious or life-threatening diseases, where appropriate, for patients who have exhausted other treatment options, and are unable to enter clinical trials.

While primarily intended for physicians, the webinar provides valuable information for anyone interested in finding out more about expanded access.

The training is applicable to all serious/life-threatening illnesses, not just cancer.

The program consists of three distinct, interactive modules:

- Introduction to Expanded Access

  • explanation of all expanded access programs available
  • Links to key references and resources that are relevant to the slide content

- Expanded Access Process

  • Information about the process from the physician, FDA, Industry and IRB perspective
  • Links to key references and resources that are relevant to the slide content

 -Investigator-Sponsor Responsibilities

  • Key information regarding legal responsibilities of physicians as investigator-sponsors
  • Links to key references and resources that are relevant to the slide content

There is no cost to access the webinar, however, if you are not an ASCO member, you will need to create a free ASCO.org Guest Account. To create your guest account, you will need to scroll down the page until you see the link to create a free ASCO.org Guest Account

 

The training modules are available at Expanded Access to Investigational Drugs Exit Disclaimer at the ASCO University web site.