What is the difference between 505j application, 505b1 NDA & 505b2 NDA?
In this topic we will be discussing about 505j, 505b1 and 505b2 application and differences between all 3 applications. The 505(j), 505(b)(1),... Read More
What is the meaning and significance of ‘First to File’ Generics?
The first to file generics submits a substantially completed Abbreviated New Drug Application to receive marketing exclusivity for 180 days. Let us... Read More