Fast-Tracking Innovation: A Guide to Leveraging the 505(b)(2) Pathway to Accelerate Drug Development
The 505(b)(2) pathway offers a strategic avenue for pharmaceutical companies to bring qualifying drugs to market more efficiently. By understanding and optimizing this pathway, companies can expedite drug development, minimize risk, and maximize return on investment, ultimately accelerating the delivery of new therapies to patients in need.
Download this guide for information on how to effectively leverage the 505(b)(2) pathway, including:
- Challenges and benefits of the 505(b)(2) pathway, including how it can be used to reduce the time and cost of development
- Differences between 505(b)(2) development and the traditional 505(b)(1) approach
- Strategic approaches and the importance of a well-coordinated, cross-functional team to navigate the 505(b)(2) pathway successfully and ensure a smooth development and approval process
