Expanded access
Expanded access (also known as compassionate use or "pre-approval access") refers to the use of an investigational new drug (IND) outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. Outside the US, such access is allowed through Named patient programs. In the US this type of access may be available, in accordance with United States Food and Drug Administration (FDA) regulations, when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, no other alternative therapy is available, and the drug developer agrees to provide access to the drug. The FDA refers to such a program as an expanded access program (EAP). EAPs
primaryTopic
Expanded access
Expanded access (also known as compassionate use or "pre-approval access") refers to the use of an investigational new drug (IND) outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. Outside the US, such access is allowed through Named patient programs. In the US this type of access may be available, in accordance with United States Food and Drug Administration (FDA) regulations, when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, no other alternative therapy is available, and the drug developer agrees to provide access to the drug. The FDA refers to such a program as an expanded access program (EAP). EAPs
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Expanded access (also known as ...... ed by the agency in June 2016.
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La cura compassionevole o uso ...... a italiana del farmaco (AIFA).
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Une autorisation temporaire d' ...... usage intérieur des hôpitaux.
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Unter dem englischen Ausdruck ...... Therapiefreiheit verstanden.“
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Link from a Wikipage to an external page
Wikipage page ID
10,843,800
Wikipage revision ID
740,553,943
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Expanded access (also known as ...... ed access program (EAP). EAPs
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La cura compassionevole o uso ...... a inglese) da quella italiana.
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Une autorisation temporaire d' ...... usage intérieur des hôpitaux.
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Unter dem englischen Ausdruck ...... che Ausdruck Compassionate Use
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label
Autorisation temporaire d'utilisation
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Compassionate Use
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Cura compassionevole
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Expanded access
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