Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presentations
Drug-Device Combination Products – A New Methodology for Evaluation
Christina Streets, MD
Senior Physician
Division of Clinical Review (DCR)
Office of Safety and Clinical Evaluation (OSCE)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Betsy Ballard, MD
Medical Officer
Division of Therapeutic Performance (DTP-I)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Approaches to Analyzing Comparative Use Human Factors Studies
Jing (Jenny) Wang, PhD
Staff Fellow
Division of Quantitative Methods and Modeling (DQMM)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)