Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 1 [Video]

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 – Keynote

19:28 – IVRT Methods for In Situ Depot-Forming Long-Acting Injectable Products

35:42 – Nano-Size Complex Products In Vitro Release Testing (IVRT)

49:13 – Application of Adaptive Perfusion as In Vitro Release Testing Method to Improve Understanding and Assessment of Complex Drug Products

01:05:03 – Session 1: Q&A Panel

Keynote:

Robert M. Califf, MD, MACC
Commissioner
U.S. Food and Drug Administration (FDA)

Session Leads:

Wenlei Jiang, PhD,
Senior Advisor for Innovation and Strategic Outreach
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD) | CDER

Yan Wang, PhD,
Lead Pharmacologist / Acting Deputy Division Director
Division of Therapeutic Performance I (DTP I)
ORS | OGD | CDER

Speakers | Panelists:

Agm (Abu) Mostofa, PhD
Pharmacologist
Division of Bioequivalence I (DBI)
Office of Bioequivalence (OB)
OGD | CDER

Thilak Mudalige, PhD
Research Chemist
Arkansas Human & Animal Food Laboratory (ARLHAF)
Office of Human & Animal Food Laboratory Operations (OHAFLO)
Office of Regulatory Science (ORS)
Office of Regulatory Affairs (ORA)

Dongkai Zhu, PhD
Visiting Associate
Division of Pharmaceutical Quality Research VI (DPQR VI)
Office of Pharmaceutical Quality Research (OPQR)
Office of Pharmaceutical Quality (OPQ) | CDER

Hee Sun Chung, PhD
Lead Pharmacologist
DBIDBI | OB | OGD | CDER

Xiaoming Xu, PhD
Division Director
Division of Pharmaceutical Quality Research V (DPQR V)
OPQR | 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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