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Maximizing Potential, Minimizing Time, Cost, & Risk: Mastering 505(b)(2) Development Strategy

Drug development pathways in the US are referred to by their corresponding section in the Federal Food, Drug, and Cosmetic Act: 505(b)(1), 505(b)(2), and 505(j). A 505(b)(1) program is generally used for novel drugs that have not been previously studied or approved, while a 505(j) program is used to develop a generic form of an innovator drug. A 505(b)(2) program on the other hand, must demonstrate safety and efficacy to the same standards as a 505(b)(1) program but at least some of the information required for approval comes from studies not conducted by or for the applicant. Because of this, when the right strategy is used, a 505(b)(2) product can often be developed with less risk, in less time, and at lower cost than a 505(b)(1) product, while obtaining market exclusivities and patent protection afforded to 505(b)(1) but not 505(j) products.

To realize the full potential of this abbreviated pathway, it is essential to plan for and execute a credibly aggressive development strategy early on. Key stakeholders in critical areas of drug development including regulatory, CMC, nonclinical, commercial, and clinical must maintain seamless communication to ensure there are no gaps when it comes time to submit the New Drug Application (NDA).

This webinar will focus on the 505(b)(2) development pathway, how it’s unique compared to other traditional development pathways, and why a well thought out development strategy with a multidisciplinary team approach is the key to avoiding missteps and achieving success.

Topics will include:

  • Qualifications for the 505(b)(2) pathway
  • Approaches to 505(b)(2) development and bridging strategies
  • How to effectively engage with the FDA
  • Common pitfalls in 505(b)(2) development


Willie Salminen, PhD, Vice President, Regulatory Toxicology and Clinical Pharmacology

Seth DePuy, PhD, Manager, Regulatory Affairs

Watch the Webinar on Demand