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Session 4: Post Approval Changes to ANDA
Speaker(s)
Peter Capella, PHD
Director, Division of Immediate and Modified Release Drug Products, Office of, Lifecycle Drug Products, Office of Pharmaceutical Quality, CDER, FDA , United States
Utpal Munshi, PHD
Division Director, Division of Bioequivalence I (DBI), Office of Bioequivalence,, Office of Generic Drugs, CDER, FDA, United States
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