Module 2b Flashcards
1
Q
NDA stands for: ___ ___ ___.
A
New Drug Application
2
Q
The NDA and IND must be filed with the ___ in the United States.
A
FDA
Food and Drug Administration
3
Q
IND stands for: ____ ____ ____.
A
Investigational New Drug application
4
Q
The IND is filed by (or on behalf of) the ____.
A
sponsor
sponsors could be changed during the approval process
5
Q
CRO: ___ ____ ____.
A
contract research organization
6
Q
IRB: ____ ____ ____.
A
investigation review board
7
Q
Studies cannot begin until after __ days after the FDA has received the IND.
A
30
8
Q
In the EU the ___ must be filed.
A
MAA
Marketing Authorization Application
9
Q
In Canada the ___ must be filed.
A
NDS
New Drug Submission
