Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presentations
Teriparatide Injection First Generic Approval: Quality-Related Review Considerations
Tina Jiao, MS
Chemist
Division of Product Quality Assessment IV (DPQA IV)
Office of Product Quality Assessment I (OPQA I)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Quality Considerations for First Generic Oral Solutions
Maria Flynn, PhD
Senior Pharmaceutical Quality Assessor
Application Technical Lead for Aligned Team 8 Unit II
Division of Product Quality Assessment VIII (DPQA VIII)
Office of Product Quality Assessment II (OPQA II)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Quality Considerations for First Generic Tiotropium Bromide Capsule-Based Dry Powder Inhalers (DPIs)
Nashwa El-Gendy, PhD
Senior Pharmaceutical Quality Assessor
Division of Product Quality Assessment V (DPQA V)
Office of Product Quality Assessment I (OPQA I)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)