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Accessing Experimental Drugs Through the Compassionate Use Doctrine

In last month's issue, we discussed how Jacob Gunvalson, when denied entry into a clinical trial for a drug that might offer treatment for his terminal disease, sued the drug manufacturer to compel it to seek a "compassionate use" exemption. We conclude with a look at the litigation that ensued.

24 minute read February 26, 2009 at 07:00 AM
By
Janice G. Inman
Accessing Experimental Drugs Through the Compassionate Use Doctrine

In last month's issue, we discussed how Jacob Gunvalson, when denied entry into a clinical trial for a drug that might offer valuable treatment for his terminal disease, Duchenne Muscular Dystrophy (DMD), sued the drug manufacturer to compel it to seek a “compassionate use” exemption from the FDA so that he could take the unapproved drug, PTC 124.

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