Drugs & Devices

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By Jordan Paradise The Food and Drug Administration (FDA) published draft guidance for industry last week detailing a streamlined process for physician submissions of individual patient requests for compassionate use of experimental drugs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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The Ethics of Using Placebo Controls in Ebola Clinical Trials

Filed in Bioethics, Drugs & Devices, Global Health by on November 25, 2014 0 Comments
The Ethics of Using Placebo Controls in Ebola Clinical Trials
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By Carl H. Coleman Cross-Posted at Bill of Health With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments.  Earlier this month, US government officials announced plans to launch a study of multiple Ebola interventions at the NIH Clinical Center, Emory […]

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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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