Understanding the 505(b)(2) Approval Pathway
Explore how the 505(b)(2) regulatory pathway can help drug developers gain approval for new drugs in a fraction of the time and cost required by traditional paths.
We’ll answer questions like:
- What is a 505(b)(2) new drug application and how does it differ from the 505(b)(1) process?
- What key regulatory, safety, and CMC challenges exist with 505(b)(2) NDA submissions?
- Is an IND required to initiate studies in 505(b)(2) development?
