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CSPAN3 Food Drug Administration Oversight January 17, 2018

Play. I want to thank allen and pew for hosting this meeting, for organizing the publishing of the special supplement and of course to mr. Gottlieb for his remarks at the beginning of the day. So the focus of this final panel today is the fact that in certain high profile cases manufacturers have released incorrect or incomplete information into the market that was directly counter to the information, the contemporaneous information the fda had. They noted that selective publication of Clinical Trial results has in the past created a misleading picture of the safety and efficacy of a product with negative implications for Public Health. And as a the practice now still stands, manufactures have wide latitude to publicly characterize data that were submitted to the fda without much risk that the fda will correct the record. I think were going to try to talk a little bit about in the next hour is, you know, in these cases does the fda have a Public Health or an ethical responsibility to c

CSPAN3 Food Drug Administration Oversight January 17, 2018

Thank you very much, josh, for that very nice introduction. I am aaron khere to introduce te final panel of the day that relates to another important set of Public Health functions, that Greater Transparency about information and regulatory decisions about the fda can play. I want to thank allen and pew for hosting this meeting, for organizing the publishing of the special supplement and of course to mr. Gottlieb for his remarks at the beginning of the day. So the focus of this final panel today is the fact that in certain high profile cases manufacturers have released incorrect or incomplete information into the market that was directly counter to the information, the contemporaneous information the fda had. They noted that selective publication of Clinical Trial results has in the past created a misleading picture of the safety and efficacy of a product with negative implications for Public Health. And as a the practice now still stands, manufactures have wide latitude to publicly ch

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Cyber security chief says MediSecure data breach is an isolated attack but warns health data a prime target for cybercrime

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