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Court deals blow to mysteriously named whistleblower, blowing off precedent
October 17, 2017
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When it comes to software as a medical device, FDA acknowledges that new technology no longer fits the old regulatory paradigm
September 19, 2017
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Is the 510(k) process as worthless as the federal courts seem to believe?
August 8, 2017
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The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials
July 27, 2017
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Congress Seeks a Statutory Fix to Stymied Off-Label Discussions
May 2, 2017
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DOJ Uses False Claims Act to Enforce FDA Manufacturing Rules
April 7, 2017
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LDTs: The Saga Continues
April 2017
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The Problem of the ‘Intended Use’ Regulations Continues to Fester
March 21, 2017
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A Phoenix Rising from The Ashes: FDA Proposes a Rule Requiring Submission of Device Labels and Package Inserts
November 29, 2016
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