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The 505(b)(2) Pathway: What is it? And What Does it Mean for Pre-IND and NDA Submission?

DownloadDate: May 29th, 2019
Presented by: Ken Phelps, president and co-founder, Camargo


To bring a new drug to market, it can take more than a decade and cost upwards of $1 billion. What if there were a way to address global patient needs faster, less expensively, and with better outcomes?

In this webinar, Camargo co-founder Ken Phelps introduces the 505(b)(2) pathway and shares expert insights on: Identifying 505(b)(2) products Navigating regulatory milestones for 505(b)(2) products including IND and NDA preparation and submission Addressing frequently asked questions and common misconceptions surrounding 505(b)(2)