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