Media Summary: Yan Wang from the Division of Therapeutic Performance in the CDER Office of Presenters Yan Wang, Bin Qin, Vidula Kolhatkar, and Bing Cai answer audience questions. Learn more at ... Presenters Cameron Smith, Deyi Zhang, and Xiaoming Xu answer audience questions. Learn more at ...

Keynote With Sally Choe 1of35 Complex Generics Sep 25 26 2019 - Detailed Analysis & Overview

Yan Wang from the Division of Therapeutic Performance in the CDER Office of Presenters Yan Wang, Bin Qin, Vidula Kolhatkar, and Bing Cai answer audience questions. Learn more at ... Presenters Cameron Smith, Deyi Zhang, and Xiaoming Xu answer audience questions. Learn more at ... Lisa Bercu, Bing Cai, Kimberly Witzmann, Office of Andrew J. Fine from the Division of Clinical Review in the Office of Kimberly Witzmann from the Office of Bioequivalence in CDER's Office of

Michelle Lin from the Division of Clinical Review in the Office of Presenters Karen Bengtson, Suneela Prodduturi and Susan Zuk answer audience questions. Learn more at ... Satish Sharan from the Division of Quantitative Methods and Modeling in the Office of Ross Walenga in the Division of Quantitative Methods and Modeling in the Office of Bryan Newman from the Division of Therapeutic Performance in the Office of Presenters Brock Roughton, Tannaz Ramezanli, Priyanka Ghosh, and Sam Raney answer audience questions. Learn more at ...

Liang Zhao, Yaning Wang, Robert Lionberger, and Murray Ducharme from Learn and Confirm, Inc., respond to audience ... Bryan Newman, Denise Conti, Kimberly Witzmann, Tian Ma, Fang Yuan, and Bhagwant Rege respond to audience questions. Karen Bengtson from the Office of Research and Standards (ORS) in the Office of Liang Zhao from the Division of Quantitative Methods and Modeling in the Office of Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of

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Keynote with Sally Choe (1of35) Complex Generics – Sep. 25-26, 2019
Complex Generics & the Prescription Drug Landscape//Dr. Sally Choe
BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019
Questions and Answers (17of35) Complex Generics – Sep. 25-26, 2019
Questions and Answers (13of35) Complex Generics – Sep. 25-26, 2019
Questions and Answers (22of35) Complex Generics – Sep. 25-26, 2019
Comparative Analyses: Injectable Combination Products (21of35) Complex Generics – Sep. 25-26, 2019
Comparative Analyses: Device and User Interface (25of35) Complex Generics– Sep. 25-26, 2019
Overview of Comparative Analyses - Clinical Perspective (19of35) Complex Generics – Sep. 25-26, 2019
Questions and Answers (4of35) Complex Generics – Sep. 25-26, 2019
Quantitative Clinical Pharmacology in LA Injectables (34of35) Complex Generics – Sep. 25-26, 2019
Credibility for Computational Fluid Dynamics Models (33of35) Complex Generics – Sep. 25-26, 2019
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Keynote with Sally Choe (1of35) Complex Generics – Sep. 25-26, 2019

Keynote with Sally Choe (1of35) Complex Generics – Sep. 25-26, 2019

Director of the Office of

Complex Generics & the Prescription Drug Landscape//Dr. Sally Choe

Complex Generics & the Prescription Drug Landscape//Dr. Sally Choe

Dr.

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BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019

BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019

Yan Wang from the Division of Therapeutic Performance in the CDER Office of

Questions and Answers (17of35) Complex Generics – Sep. 25-26, 2019

Questions and Answers (17of35) Complex Generics – Sep. 25-26, 2019

Presenters Yan Wang, Bin Qin, Vidula Kolhatkar, and Bing Cai answer audience questions. Learn more at ...

Questions and Answers (13of35) Complex Generics – Sep. 25-26, 2019

Questions and Answers (13of35) Complex Generics – Sep. 25-26, 2019

Presenters Cameron Smith, Deyi Zhang, and Xiaoming Xu answer audience questions. Learn more at ...

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Questions and Answers (22of35) Complex Generics – Sep. 25-26, 2019

Questions and Answers (22of35) Complex Generics – Sep. 25-26, 2019

Lisa Bercu, Bing Cai, Kimberly Witzmann, Office of

Comparative Analyses: Injectable Combination Products (21of35) Complex Generics – Sep. 25-26, 2019

Comparative Analyses: Injectable Combination Products (21of35) Complex Generics – Sep. 25-26, 2019

Andrew J. Fine from the Division of Clinical Review in the Office of

Comparative Analyses: Device and User Interface (25of35) Complex Generics– Sep. 25-26, 2019

Comparative Analyses: Device and User Interface (25of35) Complex Generics– Sep. 25-26, 2019

Kimberly Witzmann from the Office of Bioequivalence in CDER's Office of

Overview of Comparative Analyses - Clinical Perspective (19of35) Complex Generics – Sep. 25-26, 2019

Overview of Comparative Analyses - Clinical Perspective (19of35) Complex Generics – Sep. 25-26, 2019

Michelle Lin from the Division of Clinical Review in the Office of

Questions and Answers (4of35) Complex Generics – Sep. 25-26, 2019

Questions and Answers (4of35) Complex Generics – Sep. 25-26, 2019

Presenters Karen Bengtson, Suneela Prodduturi and Susan Zuk answer audience questions. Learn more at ...

Quantitative Clinical Pharmacology in LA Injectables (34of35) Complex Generics – Sep. 25-26, 2019

Quantitative Clinical Pharmacology in LA Injectables (34of35) Complex Generics – Sep. 25-26, 2019

Satish Sharan from the Division of Quantitative Methods and Modeling in the Office of

Credibility for Computational Fluid Dynamics Models (33of35) Complex Generics – Sep. 25-26, 2019

Credibility for Computational Fluid Dynamics Models (33of35) Complex Generics – Sep. 25-26, 2019

Ross Walenga in the Division of Quantitative Methods and Modeling in the Office of

PSG Recommendations and Updates for OINDPs (23of35) Complex Generics – Sep. 25-26, 2019

PSG Recommendations and Updates for OINDPs (23of35) Complex Generics – Sep. 25-26, 2019

Bryan Newman from the Division of Therapeutic Performance in the Office of

Questions and Answers (9of35) Complex Generic Drugs – Sep. 25-26, 2019

Questions and Answers (9of35) Complex Generic Drugs – Sep. 25-26, 2019

Presenters Brock Roughton, Tannaz Ramezanli, Priyanka Ghosh, and Sam Raney answer audience questions. Learn more at ...

Panel Questions and Discussion (35of35) Complex Generics – Sep. 25-26, 2019

Panel Questions and Discussion (35of35) Complex Generics – Sep. 25-26, 2019

Liang Zhao, Yaning Wang, Robert Lionberger, and Murray Ducharme from Learn and Confirm, Inc., respond to audience ...

Panel Questions and Discussion (28of35) Complex Generics – Sep. 25-26, 2019

Panel Questions and Discussion (28of35) Complex Generics – Sep. 25-26, 2019

Bryan Newman, Denise Conti, Kimberly Witzmann, Tian Ma, Fang Yuan, and Bhagwant Rege respond to audience questions.

Pre-ANDA Program Update (2of35) Complex Generics– Sep. 25-26, 2019

Pre-ANDA Program Update (2of35) Complex Generics– Sep. 25-26, 2019

Karen Bengtson from the Office of Research and Standards (ORS) in the Office of

Keynote from Sally Choe, Director, Office of Generic Drugs (OGD)

Keynote from Sally Choe, Director, Office of Generic Drugs (OGD)

Sally Choe

Quantitative Methods and Modeling (29of35) Complex Generics – Sep. 25-26, 2019

Quantitative Methods and Modeling (29of35) Complex Generics – Sep. 25-26, 2019

Liang Zhao from the Division of Quantitative Methods and Modeling in the Office of

Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019

Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019

Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of