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Quality Considerations for Complex Generics
Session Chair(s)
Katherine Tyner, PhD
FDA Liaison to the EMA, Office of Global Policy and Strategy, OC
FDA, United States
Increasing the availability of complex generics is a major component of FDA’s recent efforts to enhance the affordability of medicines. The complexity of these products, which includes complex active ingredients, formulations, and drug-device combinations, make both their development and the associated regulatory review challenging. In this session, FDA and industry speakers will provide an introduction to the science and risk-based considerations for developing and reviewing these important products.
Learning Objective : Discuss the definition and examples of complex generics; Describe considerations for the development of complex generics; Identify the challenges in regulatory review of complex generics.
Speaker(s)
Considerations for Manufacturing Assessment for Drug-Device Combination Products: Transdermal Systems and Intravaginal Rings
James Jefferis Norman, PhD
FDA, United States
Senior Chemist, OPF, OPQ, CDER
Strategies for Preparing High-Quality Submission of Generic Orally Inhaled Drug Products: Drug Product Quality Perspective
Fang Yuan, PhD
FDA, United States
Chemist, OLDP, OPQ, CDER
Regulatory and Scientific Challenges in Developing Generic Drug-Device Combination Products: An Auto Injector Case Study
Mike Darj, PhD
FDA, United States
Quality Assessment Lead (Acting), OLDP, OPQ, CDER
Regulatory and Scientific Challenges in Developing Generic Drug-Device Combination Products: An Auto Injector Case Study Part 2
Xiaohua Huang, PhD
FDA, United States
Chemist, Office of Lifecycle Drug Products, OPQ, CDER
Quality ANDA Considerations for Complex Generics: Industry Perspective
Scott David Tomsky, MS
Organon, United States
Associate Vice President, Regultory CMC
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