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Quality Considerations for Complex Generics
Session Chair(s)
Katherine Tyner, PHD
Senior Director, Regulatory Policy Leader EMEA & CMC
Johnson & Johnson, Netherlands
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