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ACCELERATING DRUG DEVELOPMENT: REGULATORY INITIATIVES IN THE USA
COPIES OF OVERHEADS
WHY EXPEDITE DEVELOPMENT? SAME GOAL /DIFFERENT ROLES
NEW DRUG DEVELOPMENT
STEP ONE: Know where you want to go
STEP TWO: Know your regulatory options
PPT Slide
FAST TRACK
STEP THREE:Stay in close contact with FDA review division
REGULATORY ADVICE
WHAT IS AVAILABLE?
THREE CRITICAL QUESTIONS
MEETINGS R US
DEADLY MEETINGS
INDs
Calendar Year 1998Commercial IND Receipts
DRUG DEVELOPMENT: PERFORMANCE GOALS
MEETING CATEGORIES
PERFORMANCE GOALS
DOCUMENTATION
SPECIAL PROTOCOLS
MOST CRITICAL:END OF PHASE 2 / Proof of Concept
CONCLUSIONS
REMEMBER: KNOW WHERE YOU WANT TO GO
REMEMBER KNOW YOUR REGULATORY OPTIONS AND ASK ABOUT THEM
REMEMBER COMMUNICATION IS THE KEY TO THE KINGDOM
Deputy Center Director Center for Drug Evaluation & Research US Food and Drug Administration
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Last update: July 11, 2005
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