News

Latest News | 9 May 2013

Interview: Chris Austin on Why the Public Doesn't Understand Translational Science (and why it Matters) (Part 3)

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What comes to mind when you think about federal agencies that affect healthcare product regulation? If you're like many, the first agency to come to mind is the US Food and Drug Administration (FDA), Read More...

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Latest News | 8 May 2013

Interview: Chris Austin on FDA's Wish List for Regulatory Science and Crowd-Sourcing Development (Part 2)

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What comes to mind when you think about federal agencies that affect healthcare product regulation? If you're like many, the first agency to come to mind is the US Food and Drug Administration (FDA), Read More...

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Latest News | 8 May 2013

Interview: Chris Austin on How NCATS Wants to Change Drug Development as we Know it (Part 1)

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What comes to mind when you think about federal agencies that affect healthcare product regulation? If you're like many, the first agency to come to mind is the US Food and Drug Administration (FDA), Read More...

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Latest News | 28 March 2013

Taiwan Looks to Promotion of Regulatory Science as Way to Boost Pharmaceutical Sector

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Regulatory science may be one of the biggest trends in US and EU regulatory circles, but now that fervor is making its way to a new corner of the globe: Taiwan.In a statement, Taiwan's National Cheng Read More...

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Latest News | 26 March 2013

EMA Management Board Turns Focus to Regulatory Science and Faster Approvals

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In its first meeting of 2013, the European Medicines Agency's (EMA) management board turned its sights on the agency's use of regulatory science, saying EU regulators need to adopt new approaches to Read More...

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Latest News | 29 January 2013

FDA Touts Accomplishments, Impact of Anti-AIDS Program

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US regulators are touting the success of a regulatory review program that they say has been responsible for approving dozens of drug products intended for use in developing countries—and in particular Read More...

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Latest News | 14 January 2013

NIH Announces Support for Alzheimer's Clinical Trial, Regulatory Science Initiative

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The National Institutes of Health (NIH) has announced the launch of four new clinical trials, part of a long-running initiative that hopes to find new treatments for—and maybe even entirely Read More...

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Latest News | 7 January 2013

New Regulatory Tools Requested to Study Messaging of Regulators, Industry

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How does a regulatory agency best communicate and regulate essential messaging to stakeholders on a continual basis without being ignored? The US Food and Drug Administration (FDA) isn't necessarily Read More...

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Latest News | 19 December 2012

EMA Adopts Draft ICH Guideline, Calls for Submission of Rat Carcinogenicity Studies

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The European Medicines Agency (EMA) has released for consultation a new document from the International Conference on Harmonisation (ICH), a move intended to continue the development of an existing Read More...

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Latest News | 3 December 2012

Regulatory Science Initiative Partners FDA, Medical Device Industry

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“If the U.S. wants to remain the leader in medical device innovation, we also must be the leader in regulatory science,” said Jeffery Shuren, director of the US Food and Drug Administration's (FDA)'s Read More...

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