Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 1

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

01:09 – Teriparatide Injection First Generic Approval: Quality-Related Review Considerations

18:33 – Quality Considerations for First Generic Oral Solutions

40:29 – Quality Considerations for First Generic Tiotropium Bromide Capsule-Based Dry Powder Inhalers (DPIs)

01:03:44 – Session 5A: Q&A Panel

Session Leads:

Sheela Rajesh, PhD
Senior Pharmaceutical Quality Assessor
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)

Eric Pang, PhD
Senior Chemist
Division of Therapeutic Performance I (DTP I)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD) | CDER

Speakers | Panelists:

Tina Jiao, MS
Chemist
Division of Product Quality Assessment IV (DPQA IV)
Office of Product Quality Assessment (OPQA)
OPQ | CDER

Maria Flynn, PhD
Senior Pharmaceutical Quality Assessor
Division of Product Quality Assessment VIII (DPQA VIII)
OPQA II | OPQ | CDER

Nashwa El-Gendy, PhD
Senior Pharmaceutical Quality Assessor
Division of Product Quality Assessment V (DPQA V)
Office of Product Quality Assessment I (OPQA I)
OPQ | CDER

Yili Li, PhD
Senior Pharmaceutical Quality Assessor
Division of Product Quality Assessment XI (DPQA XI)
OPQA II | OPQ | CDER

Bryan Newman, PhD
Lead Pharmacologist
DTP I | ORS | OGD | CDER

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