450.137 Access to investigational drugs, devices, and biological products for terminally ill patients.
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450.137 Access to investigational drugs, devices, and biological products for terminally ill patients.
(1)Definitions. In this section:
(a)“Eligible patient” means a patient who is eligible under sub.
(2).
(b)“Investigational drug, device, or biological product” means a drug, device, or biological product that has not been approved or licensed for use by the federal food and drug administration and meets all of the following conditions:
1. The drug, device, or biological product has successfully completed a phase one clinical trial approved by the federal food and drug administration.
2. The drug, device, or biological product remains under investigation in a phase 2 or 3 clinical trial approved by the federal food and drug administration or has completed a phase 3 clinical trial and is pending approval or licensure by the federal food and drug administration.
3. The active development or production of the drug, device, or biological product is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under 21 USC 355 (i).
(c)“Life-threatening disease or condition” means a disease or condition that is life-threatening, as defined in 21 CFR 312.81
(a).