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Commonly Occurring BE Inquiries in Post Complete Response Letter Meetings: Case Studies

Tuesday, November 9, 2021

2:30 p.m. - 3:30 p.m.

The proposed presentation will cover the inquires that occurred multiple times in Post-CR meeting requests since 2015, common inquires for which a meeting request was denied and select case studies where a meeting was either denied or granted by grouping under a specific category to increase better understanding of the program format to assist in strategies to craft appropriate questions when communicating via post-CR meetings.

Moderator: Julie Szirtes
Director, Clinical R&D, Apotex Inc.

Paramjeet Kaur, PhD 
Reviewer, Division of Bioequivalence II, OB, OGD, CDER, FDA

Hongling Zhang, PhD
Acting Director, Division of Bioequivalence II, OB, OGD, CDER, FDA

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