Back To Schedule
Tuesday, June 25 • 8:00am - 9:15am
#217: Quality Considerations for Complex Generics

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Katherine Tyner, PhD


Considerations for Manufacturing Assessment for Drug-Device Combination Products: Transdermal Systems and Intravaginal Rings
James Jefferis Norman, PhD

Strategies for Preparing High-Quality Submission of Generic Orally Inhaled Drug Products: Drug Product Quality Perspective
Fang Yuan, PhD

Regulatory and Scientific Challenges in Developing Generic Drug-Device Combination Products: An Auto Injector Case Study
Mike Darj, PhD

Regulatory and Scientific Challenges in Developing Generic Drug-Device Combination Products: An Auto Injector Case Study Part 2
Xiaohua Huang, PhD

Quality ANDA Considerations for Complex Generics: Industry Perspective
Scott Tomsky, MS


Mike Darj

Quality Assessment Lead (Acting), OLDP, OPQ, CDER, FDA
Mike has been with the Agency in various roles since 2003. He currently serves as Quality Assessment Lead (acting) in the Office of Lifecycle Drug Products of the FDA. Mike is also actively involved in working groups and expert committees as pertain to guidance and USP monograph developments... Read More →
avatar for Scott Tomsky

Scott Tomsky

Vice President, Regulatory Affairs, Generics, North America, Teva Pharmaceuticals
Scott D. Tomsky is Vice President, Regulatory Affairs, Generics, North America at Teva. He has been actively involved in the pharmaceutical industry for more than 20 years. Scott has held various positions in R&D, Quality Control and Regulatory Affairs at Johnson and Johnson, Ranbaxy... Read More →
avatar for Katherine Tyner

Katherine Tyner

Associate Director for Science, Office of Pharmaceutical Quality, CDER, FDA
Dr. Katherine Tyner is the Associate Director of Science (acting) in the Immediate Office of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA). As Associate Director, Dr. Tyner leads the OPQ... Read More →

Fang Yuan

Chemistry Reviewer, OLDP, OPQ, CDER, FDA
Fang Yuan is a Drug Product Quality Reviewer in Office of Life Cycle Drug Product (OLDP), specialized in pre-market submissions of complex generics including oral inhalation and nasal, and long-acting injectable drug products. She is involved in reviewing pre-ANDA meeting packages... Read More →

Xiaohua Huang

Chemist, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Xiaohua serves as a review chemist in the Office of Lifecycle Drug Products of the FDA. His work at FDA involves the quality assessment of abbreviated new drug applications. Prior to joining FDA, he worked in the pharmaceutical industry including Schering-Plough and then Merck on... Read More →
avatar for James Norman

James Norman

Senior Chemist, OPF, OPQ, CDER, FDA
James Norman is a senior chemist in FDA’s Office of Process and Facilities. He joined FDA in 2015, where he primarily reviews complex combination products such as transdermal systems, intravaginal rings, and microneeedles. He completed his PhD in Chemical Engineering at Georgia... Read More →

Tuesday June 25, 2019 8:00am - 9:15am PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session