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

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

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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Recommended Reading: “Google Glass and Health Care: Initial Legal and Ethical Questions”

Filed in Recommended Reading by on April 23, 2015 0 Comments
Recommended Reading: “Google Glass and Health Care: Initial Legal and Ethical Questions”

By Tara Adams Ragone As more and more potential uses of Google Glass in health care are discussed and tested, Nicolas P. Terry, Chad S. Priest, and Paul P. Szotek’s recent article, “Google Glass and Health Care: Initial Legal and Ethical Questions,” is an important read. While noting that there are a number of potential […]

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Monday Morning Recap: The Week (4.13.15-4.19.15) in Drug & Device Law & Policy

Filed in Monday Morning Recap by on April 20, 2015 0 Comments
Monday Morning Recap: The Week (4.13.15-4.19.15) in Drug & Device Law & Policy

Here’s the Monday Morning Recap, the weekly(ish) post where we call out recent drug and device law and policy developments that caught our eye and made us think. 1. Last week, the Editorial Board of the LA Times wrote in favor of a $200 monthly out-of-pocket cap on specialty drugs for individuals with marketplace plans […]

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Innovation Collaborative Tackles Persistent Problem of ER “Boarding” of Psychiatric Patients

Filed in Hospitals, Mental Health by on April 17, 2015 0 Comments
Innovation Collaborative Tackles Persistent Problem of ER “Boarding” of Psychiatric Patients

By Kate Greenwood Earlier this week, the South Jersey Behavioral Health Innovation Collaborative, a partnership among five southern New Jersey health systems, the New Jersey Hospital Association, and the Camden Coalition of Healthcare Providers, announced that it is embarking on a year-long project to study mental health care delivery in the region. As reported here, […]

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