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  5. Regulatory Education for Industry (REdI): Generic Drug Forum April 3-4, 2019 - 04/03/2019
  1. CDER Small Business & Industry Assistance (SBIA)

Education | In Person

Event Title
Regulatory Education for Industry (REdI): Generic Drug Forum April 3-4, 2019
April 3 - 4, 2019

April 3 - 4, 2019
12:00 AM - 12:00 AM ET

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Session Recordings Speaker
Keynote from Office of Generic Drugs (OGD)   Sally Choe, PhD
Office of Generic Drugs (OGD) | CDER | FDA  
Keynote from the Office of Pharmaceutical Quality (OPQ)   Michael Kopcha, PhD, RPh
Office of Pharmaceutical Quality (OPQ) | CDER | FDA  
Complex Product Development   Katherine Tyner, Christine Le  
Pre-ANDA Meeting or Controlled Correspondence?   Bhagwant Rege, Kris Andre  
Panel Questions and Discussion   Katherine Tyner, Christine Le, Bhagwant Rege, Kris Andre  
Mid-cycle Assessment Meetings, Post-complete Response Letter Meetings, Panel Questions and Discussion   Andrew Kim, Craig Kiester  
Drug Master Files (DMFs) from an Abbreviated New Drug Application (ANDA) Perspective   Lauren Woodard  
Orange Book – Its Role in ANDAs   Alicia Chen  
Referencing Approved Drug Products in ANDA Submissions   Susan Levine  
505(b)(2) NDA or ANDA?   Beth (Duvall) Goldstein, Elizabeth Friedman  
Panel Questions and Discussion   Alicia Chen, Susan Levine, Elizabeth Friedman, Beth Goldstein, Kendra Stewart
Tips on Using the CDER NextGen Collaboration Portal Kris Andre
Practical Tips on eCTD Jonathan Resnick
Update on Technical Rejection Criteria for Study Data Chao (Ethan) Chen
Panel Questions and Discussion   Kris Andre, Jonathan Resnick, Ethan Chen
Filing and Refuse to Receive (RTR) Varun Vasudeva
Phuong (Aiden) Nguyen
Assessment Tips Dat Doan
Case Studies: Inadequate Bioequivalence Studies Ke Ren
Panel Questions and Discussion   Aiden Nguyen, Varun Vasudeva, Dat Doan, Ke Ren, Julia Lee
Stability Case Studies Nusrat (Nusie) Motlekar
Frank Holcombe, Jr.
Decrease RTR, IR, and CR Due to Dissolution Deficiencies Om Anand
Impurity Case Studies: Pharmacology/Toxicology Hongbiao Liao
Victoria Keck
Panel Questions and Discussion   Nusie Motlekar, Frank Holcombe, Om Anand, Hongbio Liao, Victoria Keck  
Types of Fees and Q&A Donal Parks
Continuous Manufacturing with a Generic Perspective Sau (Larry) Lee    
Manufacturing Process and Controls: Avoiding Assessment Issues Yaodong (Tony) Huang and Vidya Pa
Deficiencies and Observations from Facility Evaluations and Inspections Vidya Pai
Panel Discussion Larry Lee, Tony Huang, Vidya Pai

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About This Event

This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. FDA will also discuss science unique to generic drug applications.

Who should attend?

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:

  • Plan to submit an ANDA or are in the process of submitting an ANDA
  • Involved in generic drug development
  • Work on bioequivalence, stability, dissolution and impurity testing
  • Submit Drug Master Files (DMFs)
  • Prepare regulatory submissions

After this course, attendees will be able to:

  • Discuss requirements for an ANDA
  • Understand and determine when to use a reference listed drug or a reference standard
  • Determine the types of FDA meetings and when to use controlled correspondence
  • Understand the factors resulting in an FDA refusal to receive decision
  • Identify common deficiencies in ANDAs including bioequivalence and quality (e.g. stability, dissolution and impurity testing)
  • Avoid common errors related to the Drug Master File (DMF)
  • And more…


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