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    Applying Ethics to Conflicting Healthcare Philosophies: The Ebola Example and the RAPS Ethics Code

    The Ebola crisis has brought more than anxiety to the US; it has brought controversy in the form of conflicting treatment recommendations for individuals returning from African countries affected by hemorrhagic fever disease. How does a regulatory professional determine how to respond in the face of conflicting philosophies on best practice for developing a treatment or prevention protocol? This article looks at the Regulatory Affairs Professionals Society (RAPS) Co...
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    Has FDA Declared any IVDs as ’Breakthrough‘ Products?

    The US Food and Drug Administration (FDA) is working to develop clarity around the in vitro diagnostic (IVD) pathway 1 at the same time its ability to regulate Laboratory Developed Tests remains under debate. 2 FDA often identifies treatments rather than IVDs as "breakthroughs" on the market so the identification of "breakthrough" IVDs is not obvious. Typically, FDA defines a "breakthrough therapy" as: 1) one to treat a serious or life-threatening disease or conditio...
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    Outstanding Contributions Deserve Outstanding Recognition

    Nominations are now open for RAPS awards, which go to regulatory professionals with diverse, global backgrounds. The RAPS Awards Committee is currently seeking nominations for RAPS' annual awards honoring outstanding regulatory professionals in the healthcare products sector. RAPS' awards programs provide an important opportunity to acknowledge outstanding individual contributors to the regulatory field. This year, the committee has made significant improvements to the...