Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 3

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

00:49 – Orally Inhaled Drug Product PSGs: General Considerations Using the Alternative Bioequivalence (BE) Approach In Lieu of Comparative Clinical Endpoint (CCEP) BE Study for Suspension-Based Metered Dose Inhalers

23:40 – Orally Inhaled Drug Product PSGs: Considerations for Using Modeling and Simulation with Alternative BE Approaches

39:09 – OPQR Testing & Research to Support Guidance Development of Inhalation Products

57:56 – Session 3: Q&A Panel

Session Leads:

Ke Ren, PhD
Acting Deputy Division Director
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for drug Evaluation and Research (CDER)

Bettina McGraw, MD, FAAP
Physician
Division of Clinical Review (DCR)
Office of Safety and Clinical Evaluation (OSCE)
OGD | CDER

Speakers | Panelists:

Liangfeng Han, MD, PhD
Clinical Analyst
Division of Therapeutic Performance I (DTP I)
Office of Research and Standards (ORS)
OGD | CDER

Ross Walenga, PhD
Senior Chemical Engineer
Division of Quantitative Methods & Modeling (DQMM)
ORS | OGD | CDER

Changning Guo, PhD
Supervisory Chemist
Division of Pharmaceutical Quality Research II (DPQR II)
Office of Pharmaceutical Quality Research (OPQR)
Office of Pharmaceutical Quality (OPQ) | CDER

Elizabeth Bielski, PhD
Senior Pharmacologist
DTP I | ORS | OGD | CDER

Zhen Xu, PhD
Senior Staff Fellow
DBIII | OB | OGD | CDER

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