Here are five things to know:
1. “Expanded access” or “compassionate use” involves using investigational medical products outside of clinical trials.
2. Physicians may use the new form to request expanded access to investigational drugs for certain patients experiencing immediately life-threatening or serious diseases.
3. These patients must not have another comparable and available therapy.
4. The FDA noted the new form is shorter than the previous form, and will take physicians about 45 minutes to complete.
5. The FDA has also released two final guidance documents. One outlines the details of expanded access, and the other explains how patients are charged for investigational drugs.
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