Drugs & Devices

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
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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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LDTs, Genomic Research & FDA Regulation: A Question of Intent

LDTs, Genomic Research & FDA Regulation: A Question of Intent
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By Jordan Paradise Last month, Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy hosted Prof. Barbara Evans, Ph.D., J.D., LL.M, as a Visiting Scholar. Prof. Evans is the George Butler Research Professor at the University of Houston Law Center; Director of the Center for Biotechnology and Law; and is […]

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FDA Guidance to Industry Streamlines Physician Compassionate Use Requests

FDA Guidance to Industry Streamlines Physician Compassionate Use Requests
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By Jordan Paradise The Food and Drug Administration (FDA) published draft guidance for industry last week detailing a streamlined process for physician submissions of individual patient requests for compassionate use of experimental drugs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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A “Money Blind” for Research into Maternal-Fetal Medication Risk?

Filed in Conflicts of Interest, Drugs & Devices by on January 16, 2015 0 Comments
A “Money Blind” for Research into Maternal-Fetal Medication Risk?
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By Kate Greenwood Cross-Posted at Bill of Health A week ago, the Food and Drug Administration announced the results of a review of the medical literature it conducted in response to “recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.” The literature, FDA determined, is inconclusive. FDA found […]

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New Disclosure Law Shines Light on Prescribing Practices

New Disclosure Law Shines Light on Prescribing Practices
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By Jordan Paradise This week, the New York Times reported that ophthalmologists who were paid to promote Genentech’s drug Lucentis (ranibizumab) were among the top billers of the drug to federal programs, exceeding the prescribing amounts of more than 75% of their peers.  Lucentis, approved in 2006 by the Food and Drug Administration (FDA), is indicated […]

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