Case Study: 505(b)(2) filing pathway – USFDA approval of Vumerity
Biogen, global biotechnology company, and Alkermes, global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Vumerity (diroximel fumarate),... Read More
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. 505(j) Application A... Read More