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Health / Prescription Drug User Fee Act / Investigational Device Exemption / Center for Devices and Radiological Health / FDA Special Protocol Assessment / Center for Drug Evaluation and Research / Premarket approval / Oritavancin / Food and Drug Administration / Pharmaceutical sciences / Medicine


Opportunities for Interactions with FDA: CDER and CDRH Perspectives
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Organization

Center for Devices and Radiological Health / FDA / Transplant and Ophthalmology Products office of Antimicrobial Products / Center for Biologics Evaluation and Research / Project Management Staff Division of Transplant / office of Device Evaluation / office of New Drugs / Food and Drug Administration / /

Person

Judit Milstein / Soma Kalb / /

Position

Acting Director / Investigational Device Exemption Program Program Operations / CDER Chief / /

Product

Soma / /

Technology

pdf / /

URL

http /

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