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Radisson Blu Plaza Hotel

Dec 14, 2023 9:00 AM - Dec 15, 2023 5:00 PM

Hyderabad Banjara Hills, 8-2-409, Rd No. 6, Banjara Hills,, Hyderabad 500034, India

DIA-US FDA-ANDA WORKSHOP: Present And Future Perspectives On Generic Drug Life Cycle Management

Session 4: Post Approval Changes to ANDA

Speaker(s)

Peter  Capella, PhD

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

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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