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By James E. Valentine — On October 1, 2019, FDA issued its second Patient-Focused Drug Development (PFDD) draft guidance – the next in ..read more
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By Riëtte van Laack — On September 30, 2019, FDA announced the availability of a draft guidance for Industry, titled “Eligibility ..read more
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By Alan M. Kirschenbaum — Buried in a recently enacted continuing appropriations act for FY 2020 is a provision amending the Medicaid ..read more
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By Rachael E. Hunt & Serra J. Schlanger & Anne K. Walsh — In a decision that could dramatically change the course of how ..read more
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By Véronique Li, Senior Medical Device Regulation Expert — Nearly three years after Section 3060(a) of the 21st Century Cures Act ..read more
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By Kurt R. Karst — Does the U.S. legal system steer researchers away from drugs that take a long time to develop?  That’s the ..read more
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By Adrienne R. Lenz, Senior Medical Device Regulation Expert — On September 27, 2019 FDA issued several updates to advance their digital ..read more
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By Adrienne R. Lenz, Senior Medical Device Regulation Expert — FDA formally announced the Safer Technologies Program (STeP) in a ..read more
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By Véronique Li, Senior Medical Device Regulation Expert & Larry J. Bauer, Senior Regulatory Drug Expert & Sarah Wicks* — There ..read more
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By Riëtte van Laack — On August 22, 2019, the consumer advocacy organization Truthinadvertising.org (“TINA.org”) submitted a ..read more

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