This column summarizes New Drug Applications (NDAs) for the third quarter 2014 (July through September 2014). In this quarter, FDA approved 38 NDAs.
Thursday, February 05, 2015
New Drug Application (NDA) approval involves various steps including pre-clinical research, investigational new drug application, clinical studies, and NDA review. NDAs can be obtained for new molecules or for existing drug molecules with a new ...
Monday, December 01, 2014
Receiving an approval for a New Drug Application (NDA) is something special for every pharmaceutical company. NDAs can be obtained for new molecules or for existing drug molecules with a new formulation
or for a new indication. In this column, we ...