Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presentations
Guidance for Industry: Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs
Greg Huang, PhD
Senior Chemist
Division of Product Quality Assessment IX (DPQA IX)
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)
Analysis of First Cycle ANDA Approval and Major Deficiencies Encountered from In Vitro and In Vivo Bioequivalence Study Perspectives
Fang Lu, PhD
Lead Pharmacologist
Division of Bioequivalence I (DBI)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Priyanka Ghosh, PhD
Lead Pharmacologist
Division of Therapeutic Performance I (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)
ICH M13A: First ICH Guideline for Bioequivalence
Lei Zhang, PhD
Deputy Director
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs: First-Year Review
Yuqing Gong, PhD
Senior Pharmacologist
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)