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Pharmaceuticals policy / Pharmaceutical sciences / Prescription Drug User Fee Act / Center for Biologics Evaluation and Research / Criticism of the Food and Drug Administration / FDA Special Protocol Assessment / Food and Drug Administration / Medicine / Health


FDA-Industry PDUFA V Reauthorization Meeting
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Company

Steering Group / Johnson & Johnson / Genzyme / /

Facility

MD Building / FDA White Oak Campus / /

IndustryTerm

supplemental applications / manufacturing changes / prior approval manufacturing supplements / prior-approval manufacturing supplements / telephone consultation / /

Organization

FDA / Advisory Committee / /

Person

John Jenkins Chris Joneckis Bob / Bob Yetter Matt Sullivan Dave / David Wheadon Jeffrey Francer / Jay Siegel David Wheadon Jeffrey / Dave Roeder Wade Ackerman / Patrick Frey John Jenkins Chris / Matt Sullivan Dave Roeder Wade / Sara Radcliffe Jay Siegel David / Kay Holcombe Sara Radcliffe Jay / Chris Joneckis Bob Yetter Matt / /

Position

Major / / /

SocialTag