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ON DEMAND - Quality Considerations for Complex Drugs
Session Chair(s)
M. Scott Furness, PHD
Deputy Director, Office of New Drug Products, OPQ, CDER
FDA, United States
Complex drugs can often have unique scientific and regulatory challenges related to product quality that are not commonly encountered with more conventional small molecule drugs. Examples of such complex drugs include botanicals, oligonucleotides, and generic peptides.
Learning Objective : Discuss some of the unique scientific and regulatory challenges associated with botanicals, oligonucleotides, and generic peptides drugs including navigating frequently seen quality issues that may arise during later phases of drug development; Outline how to proactively identify critical quality attributes associated with these drugs to help mitigate product risk.
Speaker(s)
Unique CMC Challenges Associated With Botanical Drug Review
Charles G. Wu, PHD
FDA, United States
Expert Pharmacologist, OPQ, CDER
Complex Peptide ANDAs: Test and Reference Product Comparability Studies from a Quality Perspective
Cameron J Smith, PHD
FDA, United States
Senior Chemist, OLDP, OPQ, CDER
Quality Considerations for Oligonucleotide Therapeutics
Nanda K. Subbarao, PHD
Biologics Consulting, United States
Group Leader, CMC Development