Kate Rawson on Muck Rack

Kate Rawson

over by the bar
Senior Editor, Prevision Policy — Pharma Intelligence

Drug regulation/health policy journalist, downhill skier, cyclist, Mom to two, school choice supporter, library lover, Baltimore believer. Tweets are all me.

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@Kate_Rawson — 376 followers, 925 tweets

@US_FDA and transparency: new pilot would release "clinical study reports" for nine novel NDAs to support new research; since pilot is voluntary, the question is: will sponsors jump?  https://goo.gl/HSPVxM 
Letters than detail drug safety issues would be among those most important to release, @SGottliebFDA says.
@US_FDA exploring ways to release "subset" of Complete Response Letters under current statute. @SGottliebFDA says only those that would inform clinical practice (e.g. not those detailing GMPs issues)
RT @Laura_H: Woodcock: FDA tried using a contractor to clean up some "really old labels" and what they got back wasn't usable. "…
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