Zachary Brennan on Muck Rack

Zachary Brennan

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Washington, DC
Managing Editor — Regulatory Focus

Managing editor for @RAPSorg's Regulatory Focus. Views are mine. zbrennan@raps.org

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@ZacharyBrennan — 3,533 followers, 9,830 tweets

RT @AlecGaffney: Death penalty meets FDA regulation of 503A/B facilities. A good read for the regulatory wonks among you.  https://twitter.com/csmcdaniel/status/965962451903795205 
$SRPT weighs FDA draft guidance on targeted therapies for low-freq. molecular subsets of a disease  https://www.regulations.gov/document?D=FDA-2017-D-6617-0008 
Remember the orphan drug designation "loophole" that FDA said it was closing? @IAmBiotech says it's not a loophole (said in the Arnold voice from Kindergarten Cop)... as FDA was the one that came up w/that legal interpretation  https://www.raps.org/news-and-articles/news-articles/2018/2/orphan-designation-loophole-stakeholders-support 
FDA final rule out this morn: Device data collected outside the US must conform to good clinical practice regs  https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-03244.pdf 
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