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Health / Pharmaceutical sciences / Prescription Drug User Fee Act / Federal Food /  Drug /  and Cosmetic Act / Center for Biologics Evaluation and Research / New Drug Application / Patent application / Biologic License Application / FDA Special Protocol Assessment / Food and Drug Administration / Pharmaceuticals policy / Medicine


SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities
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Company

C. Manufacturing / U.S. Bank / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

large volume parenteral drug product / manufacturing use / biological products / pharmaceutical industry / drug product / annual product / medical devices / blood products / Internet Web site / human drug applications / biologic license applications / diagnostic biologic product / biologic products / on-line user fee cover sheet / manufacturing / Web link / /

Movie

Cord / /

Organization

Federal government / C. Office / FDA / CBER PDUFA / Center for Drug Evaluation and Research / office of Financial Management / Center for Biologics Evaluation and Research / United States government / /

Person

Carla Vincent Robert Yetter / Conley Darcel Bigelow Roger Eastep Chris / Roger Eastep Chris Nemoff Carla / Roger Eastep Robert Yetter / Chris Nemoff Carla Vincent Robert / /

Position

D. Regulatory Project Manager / Director / Associate / Commissioner / Center Director / Associate Director for Review Management / General / Regulatory Project Manager / Director for Review Management / Business Operations / Director for Review Management / Business Operations Staff / /

Product

certain human drug / /

Technology

stem cells / /

SocialTag