Sponsored Webcast: Winning FDA Approval for Generic Combination Drugs: Key Regulatory Strategies (On Demand)
Generic combination drug product applications (Abbreviated New Drug Applications-ANDA) are rapidly increasing, driven by the rise of GLP-1 drugs. In this one-hour webcast, you'll receive detailed regulatory guidance on how to achieve US Food and Drug Administration (FDA) approval for generics and interchangeable biosimilars using the human factors comparative process. Topics include device selection, labeling development, comparative analyses, and comparative use human factors (CUHF) studies. Attendees will learn how to overcome common regulatory and human factors challenges that often delay or derail ANDA sponsors. The session will also cover the FDA’s distinct regulatory approach to ANDA versus new drug applications (NDA), frequent mistakes made during the process, why the FDA guidance alone will not lead to success, key decision points for regulatory professionals, and strategies to improve your chances of a successful submission and review.
Registration Fees & Deadlines
Member: $0 | Nonmember: $50
Learning Objectives
- Avoid costly mistakes: understand the most common and expensive errors made by pharma and biotech companies when developing generic combination drug products, and how to prevent them
- Conduct FDA-acceptable device comparisons: learn how to analyze differences between your proposed device and the reference device in a way that meets FDA expectations
- Assess CUHF study requirements independently: discover how to determine whether a comparative use human factors (CUHF) study is needed without having to consult the FDA, saving time and resources
- Design a compliant CUHF protocol: gain practical guidance on how to construct a CUHF study protocol that aligns with FDA standards and avoids common pitfalls
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speaker
Anthony Andre, PhD, CPE
Director, Interface Analysis Associates
Anthony Andre, PhD, CPE is a world-recognized thought leader in healthcare human factors. He is Director of Interface Analysis Associates LLC, a leading healthcare human factors consultancy in business since 1993, a professor of human factors/ergonomics at San Jose State University, the founding chair of the International Symposium on Human Factors and Ergonomics in Healthcare and the founding Editor-in-Chief of the journal "Human Factors in Healthcare." Andre and his staff have been at the forefront of the combination drug product ANDA movement, having managed and executed dozens of ANDA human factors programs for pharma and biotech sponsors all over the world. His experience covers numerous drugs (e.g., Ozempic, Saxenda, Mounjaro, Wegovy, Lantus, Aspart) and device types (e.g., pens, autoinjectors, pre-filled syringes, inhalers, nasal sprays). Andre has provided human factors training to the FDA reviewers and for 10 years moderated an annual FDA-Industry human factors workshop.
