CDiddy is correct. According to the FDA The fo
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Posted On: 05/26/2020 2:57:50 PM
Re: Rex Eupseiphos #35437
CDiddy is correct.
According to the FDA The following criteria must ALL be met to be eligible for compassionate use:
-Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
-There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
-Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
According to the FDA The following criteria must ALL be met to be eligible for compassionate use:
-Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
-There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
-Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
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