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Compassionate Use And Expanded Access Programs

Compassionate Use - Individual Special Exemptions

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If you don't qualify for a clinical trial or an Expanded Access Program, you can still request an individual special exemption which gives you permission to take a drug on a "compassionate use" or "compassionate exception" basis.

If the drug is in a clinical trial for which you don't qualify, you can attempt to get permission from the people involved in the clinical trial or apply to the FDA for an individual exemption.

Drug makers often provide drugs to individuals on a so-called "compassionate use" basis. The criteria for enlisting in these programs differs from company to company. Some companies have no policy and give approval on a case-by-case basis.

The FDA will consider each request on a case-by-case basis, to decide whether it agrees that there is a reasonable chance the drug will prolong survival or improve a person's quality of life. The FDA usually makes this decision within a few days after receiving the request.

To find such a drug:

  • Ask your specialist.
  • Speak with patient advocacy organizations that specialize in your health condition.
  • Search chat rooms on the internet of groups of people with your health condition.

In order to receive an individual special exemption you will need the cooperation of your doctor at least to obtain your treatment history.

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