Advancing Generic Drug Development: Translating Science to Approval 2023 - Day 1 - Part 1

Commissioner of Food and Drugs, Robert M. Califf MD, MACC, delivers his Keynote Address to the 2023 Advancing Generic Drug Development: Translating Science to Approval conference. Following the keynote is the start of session one: Noteworthy Guidances and Generic Approvals for Topical and Transdermal Products.
Timestamps
00:04 - Keynote
14:41 - General Guidances Related to Characterization-Based Bioequivalence Approaches for Topical Products - Part I
25:13 - General Guidances Related to Characterization-Based Bioequivalence Approaches for Topical Products - Part II
44:33 - An Overview of the Current Product-Specific Guidances for Topical Products
01:02:45 - How Research Supports Product-Specific Guidances for Topical Products
Speakers:
Robert M. Calif, MD, MACC
Commissioner of Food and Drugs
U.S. 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) | FDA
Hiren Patel, PhD
Senior Staff Fellow
Division of Bioequivalence II (DB II)
Office of Bioequivalence (OB) | OGD | CDER
Megan Kelchen, PhD
Senior Pharmacologist
DTP I | ORS | OGD | CDER
Ahmed Zidan, PhD
Senior Staff Fellow
Division of Product Quality Research (DPQR)
Office of Testing and Research (OTR)
Office of Pharmaceutical Quality (OPQ) | CDER
Learn more at: www.fda.gov/dr...
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