(Total Views: 525)
Posted On: 09/24/2021 8:44:06 AM
Post# of 72446
Mo, I asked a recently retired Dr Friend of mine about the conditions the FDA required for Compassionate Use. Here is my question:
“Doesn’t the FDA require more than Tox study success before approving Compassionate Use authorization?”
His response:
“Some efficacy studies also They’re most concerned with safety, less so efficacy”
After thinking about this I can see where the FDA wanted to ensure the product passed Tox studies, but also showed some efficacy, but safety was the primary concern. Then because the patient was in dire straits, it would then be up to them and their Dr to make the decision to “try” what might be a life saving drug.
I see this as a person and his/her Dr saying what do we have to lose? My hope is that the Drs at the trial sites saw significant improvement and are requesting Compassionate Use for others.
“Doesn’t the FDA require more than Tox study success before approving Compassionate Use authorization?”
His response:
“Some efficacy studies also They’re most concerned with safety, less so efficacy”
After thinking about this I can see where the FDA wanted to ensure the product passed Tox studies, but also showed some efficacy, but safety was the primary concern. Then because the patient was in dire straits, it would then be up to them and their Dr to make the decision to “try” what might be a life saving drug.
I see this as a person and his/her Dr saying what do we have to lose? My hope is that the Drs at the trial sites saw significant improvement and are requesting Compassionate Use for others.
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