Question

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 1

The Correct Option is C

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.