Drug dev process Flashcards
1
Q
YEARS FOR PRECLINICAL
A
3.5 to 6.5 yrs
2
Q
After preclinical
A
File IND with FDA
3
Q
PHASE I
A
1 to 1.5yrs
4
Q
PHASE II
A
2yrs
5
Q
PHASE III
A
3 to 3.5yrs
6
Q
AFTER PHASE III
A
File NDA with FDA
7
Q
AFTER NDA
A
FDA REVIEW PROCESS
1-2.5yrs
8
Q
AFTER 15YRS ADDITIONAL MARKETING
A
PHASE IV
