SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Generic Drug Forum 2019

Download the Agenda   –   Presenter Bios

ZIP of Day One Slides   –   ZIP of Day Two Slides

Day 1: April 3, 2019:

Keynote from Office of Generic Drugs (OGD)
Sally Choe
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Keynote from the Office of Pharmaceutical Quality (OPQ)
Michael Kopcha
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Complex Product Development
Katherine Tyner
Christine Le
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Pre-ANDA Meeting or Controlled Correspondence?
Bhagwant Rege
Kris Andre
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Panel Questions and Discussion
Katherine Tyner, Christine Le, Bhagwant Rege, Kris Andre
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Mid-cycle Assessment Meetings
Andrew Kim
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Post-complete Response Letter Meetings
Andrew Kim
Ankara (Nikki) Yokum
Recording included above
Panel Questions and Discussion
Andrew Kim, Nikki Yokum
Recording included above
Drug Master Files (DMFs) from an Abbreviated New Drug Application (ANDA) Perspective
Lauren Woodard
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Orange Book – Its Role in ANDAs
Alicia Chen
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Referencing Approved Drug Products in ANDA Submissions
Susan Levine
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505(b)(2) NDA or ANDA?
Elizabeth Friedman
Beth (Duvall) Goldstein
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Panel Questions and Discussion
Alicia Chen, Susan Levine, Elizabeth Friedman, Beth Goldstein, Kendra Stewart
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Practical Tips on Using the CDER NextGen Collaboration Portal
Kris Andre
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Practical Tips on eCTD
Jonathan Resnick
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Submission of Study Data
Chao (Ethan) Chen
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Panel Questions and Discussion
Kris Andre, Jonathan Resnick, Ethan Chen
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Day 2: April 4, 2019:

Filing and Refuse to Receive (RTR)
Varun Vasudeva
Phuong (Aiden) Nguyen
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Assessment Tips
Dat Doan
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Bioequivalence Case Studies
Ke Ren
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Panel Questions and Discussion
Aiden Nguyen, Varun Vasudeva, Dat Doan, Ke Ren, Julia Lee
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Stability Case Studies
Nusrat (Nusie) Motlekar
Frank Holcombe, Jr.
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Dissolution Case Studies
Om Anand
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Impurity Case Studies
Hongbiao Liao
Victoria Keck
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Panel Questions and Discussion
Nusie Motlekar, Frank Holcombe, Om Anand, Hongbio Liao, Victoria Keck
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Types of Fees
Donal Parks
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Continuous Manufacturing with a Generic Perspective
Sau (Larry) Lee
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Manufacturing Process and Controls: How to Avoid Major Assessment Issues Turning into Potential Deficiencies/Approvability Issue
Yaodong (Tony) Huang
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Deficiencies and Observations from Facility Evaluations and Inspections
Vidya Pai
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Panel Questions and Discussion
Larry Lee, Tony Huang, Vidya Pai
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