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Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process
Rescue Me: The Challenge Of Compassionate Use In The Social Media Era
Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework
Applying Comparative Effectiveness Research To Individuals: Problems And Approaches
The Privacy Conundrum And Genomic Research: Re-Identification And Other Concerns
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Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process
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...
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Mon, Nov 11 2014 6:00 AM
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Rescue Me: The Challenge Of Compassionate Use In The Social Media Era
The Development of Brincidofovir and its Possible Use to Treat Josh Hardy Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection...
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Wed, Aug 08 2014 9:29 AM
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Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework
Editor's note: In addition to Meaghan George, Sara Bencic and Darshak Sanghavi also coauthored this post. Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development...
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Thu, Jul 07 2014 12:12 PM
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Applying Comparative Effectiveness Research To Individuals: Problems And Approaches
A Comparative Effectiveness Research (CER) study shows that surgery is better than medical treatment for a particular cardiac condition. My patient is 78 years old and has complicated diabetes. – does the study apply? Another patient 48 years old and...
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Tue, Oct 10 2013 7:36 AM
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The Privacy Conundrum And Genomic Research: Re-Identification And Other Concerns
No matter what the arena -- finance, health care, or national security -- questions surrounding the provision of personal data are always the same: how much benefit vs. how much risk? Who handles these data, and can those individuals be trusted? How do...
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Wed, Sep 09 2013 6:00 AM
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Seven Ways For Health Services Research To Lead Health System Change
With ACA implementation now at hand -- and with it, the formation of accountable care organizations (ACOs) -- health services research (HSR) has an especially important role to play. As ACOs take steps that will substantially change health care delivery...
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Thu, May 05 2013 11:52 AM
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Reforming the Research Regulatory System
There is a growing consensus that the regulatory system for research is in need of reform . Established 21 years ago by the Common Rule, it has functioned via a rigorous environment to assure that risk in research is dealt with and transparency maintained...
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Wed, Apr 04 2013 11:26 AM
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A Cure For Patent Pathology? The Supreme Court Reviews The Patentability Of Human Genes
“Are human genes patentable?” On November 30, 2012, the U.S. Supreme Court agreed to answer this single question in Association for Molecular Pathology v. Myriad Genetics . Of course, the petitioners, including health care providers, professional associations...
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Fri, Dec 12 2012 8:39 AM
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Misguided Genetic Exceptionalism
While society should be careful about its uses of genetic testing and its efforts to modify the genome, some people overreact when dealing with DNA. Consider two recent examples reported in the media. A genetic cancer test. In a fascinating series on...
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Fri, Aug 08 2012 8:46 AM
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Reflections On AIDS 2012
Editor’s note: The current issue of Health Affairs is a thematic volume focusing on the President’s Emergency Plan For AIDS Relief (PEPFAR). Last week’s 19th International AIDS Conference in Washington, D.C. convened 25,000 scholars, activists...
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Wed, Aug 08 2012 5:30 AM
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Get A Grippe: Lessons Learned From The Controversy Over Publication Of Pandemic Flu Research
If one were to try and identify what issue has most roiled the biomedical community in the past few months it is surely the effort to censor two papers describing genetic modifications of the H5N1 flu virus. Background. Last December, the U.S. National...
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Tue, May 05 2012 8:54 AM
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Adolescents And Young Adults: Bringing A Neglected Group Into Cancer Research
“A child is not a small adult,” but an adolescent is not a large child. Adult oncologists, reluctant to care for cancer patients under the age of 16, believe that adolescent and young adult (AYA) cancer patients should be within their purview. We...
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Fri, Jan 01 2012 9:16 AM
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