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Accelerating Drug Development:
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Table of ContentsACCELERATING DRUG DEVELOPMENT: REGULATORY INITIATIVES IN THE USA WHY EXPEDITE DEVELOPMENT? SAME GOAL /DIFFERENT ROLES STEP ONE: Know where you want to go STEP TWO: Know your regulatory options STEP THREE: Stay in close contact with FDA review division Calendar Year 1998 Commercial IND Receipts DRUG DEVELOPMENT: PERFORMANCE GOALS MOST CRITICAL: END OF PHASE 2 / Proof of Concept REMEMBER: KNOW WHERE YOU WANT TO GO |
Author: Murray M. Lumpkin, M.D.
Deputy Center Director |
Last update: July 11, 2005
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