Penelope
Diamond Member
- Jul 15, 2014
- 60,260
- 15,767
- 2,210
compassionate.
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What to Expect After Submitting a Request for Expanded Access to an Investigational Drug (Including a Biologic) Under a Single Patient IND
· FDA authorizes over 99% of expanded access requests it receives.
· Treatment may begin 30 days after FDA receives the IND, or earlier if FDA notifies the treating physician that the expanded access use may begin. The treating physician must ensure that IRB review is obtained in accordance with FDA’s regulations.
· The treating physician may need to provide the IND application number to the medical product company prior to the company shipping the investigational drug. This number will be provided upon FDA authorization of the expanded access request.
Expanded Access (Compassionate Use)
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Dead On Arrival: Federal “Compassionate Use” Leaves Little Hope for Dying Patients | Right to Try - National Movement
Right to try has already been passed by many states, nothing new here. Also the med has to go under the first clinical trial.
So are insurance companies going to pay for the med, NO.
Will drug companies make new meds and pass them out to the dying, probably not. LAWSUITS.
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Trump made no laws just signed a bill to make it federal and most states have it anyway. Just a photo op for Trump.
This leaves drug companies to pass out pills like sugar , well after a first clinical trial.
But if you are going to die, why not try all the chemicals you want. You will still need a doctor to follow you but accurate reporting will not be done under the FDA probably, just bypassing the FDA.
Be careful.
----------------------------------------------------
What to Expect After Submitting a Request for Expanded Access to an Investigational Drug (Including a Biologic) Under a Single Patient IND
· FDA authorizes over 99% of expanded access requests it receives.
· Treatment may begin 30 days after FDA receives the IND, or earlier if FDA notifies the treating physician that the expanded access use may begin. The treating physician must ensure that IRB review is obtained in accordance with FDA’s regulations.
· The treating physician may need to provide the IND application number to the medical product company prior to the company shipping the investigational drug. This number will be provided upon FDA authorization of the expanded access request.
Expanded Access (Compassionate Use)
-----------------------------------------------------------------
Dead On Arrival: Federal “Compassionate Use” Leaves Little Hope for Dying Patients | Right to Try - National Movement
Right to try has already been passed by many states, nothing new here. Also the med has to go under the first clinical trial.
So are insurance companies going to pay for the med, NO.
Will drug companies make new meds and pass them out to the dying, probably not. LAWSUITS.
---------------------------------------------------------------
Trump made no laws just signed a bill to make it federal and most states have it anyway. Just a photo op for Trump.
This leaves drug companies to pass out pills like sugar , well after a first clinical trial.
But if you are going to die, why not try all the chemicals you want. You will still need a doctor to follow you but accurate reporting will not be done under the FDA probably, just bypassing the FDA.
Be careful.
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