Understanding the 505(b)(2) Approval Pathway

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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?