PTM1, you just hit the nail on the head, and it ap
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(Total Views: 509)
Posted On: 04/13/2020 7:39:04 PM
PTM1, you just hit the nail on the head, and it applies now that it is under a trial protocol. At least the way I read it.
The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.
An eligible patient is a patient who has:
Been diagnosed with a life-threatening disease or condition
Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
And has provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physician
An eligible investigational drug is an investigational drug:
For which a Phase 1 clinical trial has been completed
That has not been approved or licensed by the FDA for any use
For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA
Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA
If you are interested in Right to Try, you should discuss this pathway with your licensed physician. Companies who develop and make drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under Right to Try and if they are able to provide the drug/biologic under the Right to Try Act. Ultimately, sponsors developing drugs for life-threatening diseases or conditions are responsible for determining whether to make their products available to patients who qualify for access under the Right to Try Act.
The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.
An eligible patient is a patient who has:
Been diagnosed with a life-threatening disease or condition
Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
And has provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physician
An eligible investigational drug is an investigational drug:
For which a Phase 1 clinical trial has been completed
That has not been approved or licensed by the FDA for any use
For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA
Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA
If you are interested in Right to Try, you should discuss this pathway with your licensed physician. Companies who develop and make drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under Right to Try and if they are able to provide the drug/biologic under the Right to Try Act. Ultimately, sponsors developing drugs for life-threatening diseases or conditions are responsible for determining whether to make their products available to patients who qualify for access under the Right to Try Act.
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