Question
Clinical Pharmacy and Therapeutics Question on Clinical Trial Fundamentals
When a New Drug Application (NDA) made?
A
Once the animal studies are done and drug is declared safe in animals.
B
Once the animal studies are done and drug declared safe and effective in animals study.
C
After the phase III clinical trial.
D
After the phase IV clinical trial.
Answer
After the phase III clinical trial.
Explanation
Solution
The correct option is (C):After Phase III Clinical trials A 'new drug application' (NDA) is submitted to the licensing authority (like FDA), who if convinced give marketing permission.
Note: 'Restricted marketing permission for use only in hospitals with specific monitoring facilities.