Tag: Compassionate Use

J&J Leads the Way in Developing a Rational Process for Responding to Compassionate Use Requests

Filed in Clinical Research, Drugs & Devices by on May 15, 2015 0 Comments
J&J Leads the Way in Developing a Rational Process for Responding to Compassionate Use Requests

By Carl H. Coleman Global pharmaceutical giant Johnson & Johnson announced last week that it had appointed Arthur Caplan, a prominent bioethicist, to establish a Compassionate-Use Advisory Committee (CompAC) to make decisions about patients’ requests for access to unapproved medications outside of clinical trials.  The decision is a welcome development that other companies would be […]

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FDA Guidance to Industry Streamlines Physician Compassionate Use Requests

FDA Guidance to Industry Streamlines Physician Compassionate Use Requests

By Jordan Paradise The Food and Drug Administration (FDA) published draft guidance for industry last week detailing a streamlined process for physician submissions of individual patient requests for compassionate use of experimental drugs undergoing active clinical trials. Entitled Individual Patient Expanded Use Access Applications: Form FDA 3926, this guidance builds on a well-established system of […]

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Ebola Outbreak Shines a Light on Compassionate Use

Ebola Outbreak Shines a Light on Compassionate Use

The Ebola outbreak, which has claimed nearly 1,000 lives since its emergence in West Africa in December 2013, has brought renewed attention to policies surrounding the “compassionate use” of unapproved medications – i.e., the provision of unapproved medications to individuals outside the context of clinical trials.   The issue rose to the forefront early last week […]

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