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Session 3: Quality Considerations for Generic Drug-Device Combination Products (Continued)
Session Chair(s)
Susan Rosencrance, PhD
Acting Director, Office of Generic Drugs, CDER
FDA, United States
Session 3: Quality Considerations for Generic Drug-Device Combination Products (Continued)
Speaker(s)
Panelist
Bing Cai, PhD
FDA, United States
Division Director, OPQ, CDER
Panelist
Intira Coowanitwong
FDA, United States
Acting Quality Assessment Lead, OPQ, CDER
Panelist
Gary Henniger
Teva Pharmaceuticals, United States
Sr Director, Global Device R&D Operations
Panelist
Steven Hertz, MBA, MS
FDA, United States
Consumer Safety Officer, Office of Pharmaceutical Quality, CDER
Panelist
James Jefferis Norman, PhD
FDA, United States
Senior Chemist, OPF, OPQ, CDER
Panelist
Brock Roughton
FDA, United States
Acting Quality Assessment Lead, OPQ, CDER
Panelist
Alan Stevens, MS
FDA, United States
Acting Division Director, Division of Drug Delivery, General Hospital and Human