Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
Sample 1
1. 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