FDA experts demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in ANDAs alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA and ANDA meeting discussions.
Timestamps
01:17 – Totality of Evidence Including Physiologically Based Pharmacokinetic (PBPK) Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets
24:49 – Challenges and Progress in Emerging Complex Generic Oligonucleotide Products
47:03 – The Journey of First Approvals of Complex Generic Long-acting Injectable Products
01:16:15 – Session 5B: Q&A Panel
Session Leads:
Deyi Zhang, PhD
Senior Chemist
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)
Ross Walenga, PhD
Senior Chemical Engineer
Division of Quantitative Methods & Modeling (DQMM)
ORS | OGD | CDER
Speakers | Panelists:
Yang Lu, PhD
Senior Staff Fellow
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)
OGD | CDER
Fang Wu, PhD
Senior Pharmacologist
DQMM | ORS | OGD | CDER
Likan Liang, PhD
Supervisory Chemist
Division of Product Quality Assessment X (DPQA X)
Office of Product Quality Assessment II (OPQA II)
Office of Pharmaceutical Quality (OPQ) | CDER
Yan Wang, PhD
Lead Pharmacologist / Acting Deputy Division Director
DTP I | ORS | OGD | CDER
Hansong Chen, PharmD
Senior Interdisciplinary Scientist
Division of Product Quality Assessment XII (DPQA XII)
OPQA II | OPQ | CDER
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-translating-science-approval-2024-09242024
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