Clinical Investigation Phase III: Process Overview

PRE-CLINICAL RESEARCH CLINICAL STUDIES NDA REVIEW

SYNTHESIS AND

PURIFICATION

ANIMAL

TESTING

NDA SUBMITTED

ADVISORY COMMITTEES

SPONSOR/FDA MEETINGS ENCOURAGED

INSTITUTIONAL

REVIEW BOARDS

SPONSOR ANSWERS

ANY QUESTIONS

FROM REVIEW

REVIEW

DECISION

ACCELERATED DEVELOPMENT REVIEW

TREATMENT IND

PARALLEL TRACK

PHASE 1

PHASE 2

PHASE 3

LONG-TERM

SHORT-TERM

EARLY ACCESS

E

E

E

SUBPART E

IND SUBMITTED

E

INDUSTRY TIME

FDA TIME