2024 - Maximizing Potential, Minimizing Time, Cost, & Risk: Mastering 505(b)(2) Development Strategy

In the US, drug development pathways 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 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, chemistry, manufacturing and control (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).
Register for this webinar today to gain insights into the 505(b)(2) development strategy and how it is unique compared to other traditional drug development pathways. The featured speakers will discuss why a well-thought-out development strategy with a multidisciplinary team approach is the key to avoiding missteps and achieving success.
Keywords: FDA, Drug Development, Drug Approval, Drug Discovery, Drug Safety, FDA Approval, New Drug Approval, Investigational New Drug, Regulatory, FDA Guidance, NDA, CMC