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?
- 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)