Food and Drug Administration (FDA)

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By Jordan Paradise The Food and Drug Administration (FDA) published draft guidance for industry last week detailing a streamlined process for physician submissions of individual patient requests for compassionate use of experimental drugs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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Battle Lines Drawn over Biosimilar Application and Patent Disclosure Process

Battle Lines Drawn over Biosimilar Application and Patent Disclosure Process
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By Jordan Paradise The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the generic arena over […]

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Last Week for Comments on Proposed FDA Guidance on 3-D Printed Medical Devices

Last Week for Comments on Proposed FDA Guidance on 3-D Printed Medical Devices
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By Nicole Stuver Three-dimensional scanning, modeling, and printing have become an emerging field of diagnosing and treating maladies.  This technology has enabled advances in neurology, dentistry, orthodontics, orthopedics, cardiology, oncology and other fields of practice.  These new technologies are revolutionary particularly because they have the capability to be customized for each individual patient.  President Obama […]

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What’s Next If the FDA Holds the Line on Social Media?

What’s Next If the FDA Holds the Line on Social Media?
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Cross-Posted at Bill of Health Earlier this week, the Food and Drug Administration announced that it was reopening the comment periods for the two draft guidances on the use of social media to promote prescription drugs and medical devices that it released in June:  Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for […]

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