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  4. FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop - 05/04/2020 - 05/04/2020
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Workshop

Event Title
FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop
May 4, 2020


Date:
May 4, 2020
Time:
8:30 AM - 4:30 PM ET

Meeting Information

  • Date: Monday, May 4, 2020, from 8:30 - 4:30pm

Overview

FDA held a science-focused public workshop to provide an overview of the status of the current FY 2020 Generic Drug User Fee Amendments (GDUFA) Science and Research Priorities as well as solicit input on the development of next year’s (FY 2021) priorities.

This workshop is an integral part of the agency’s GDUFA commitments. We will carefully consider the input provided at the public workshop when we develop the FY 2021 GDUFA Science and Research Priorities. These priorities support product-specific guidance development, the review of Abbreviated New Drug Application (ANDA) submissions, and the pre-ANDA program outlined in the GDUFA commitment letter.

This year’s workshop introduces two exciting new opportunities:

  • Virtual Attendance
  • Industry Leaders’ Roundtable - Join us for a discussion with industry leaders about the current landscape of FDA’s research program and their perspective on various topics related to generic drug development.
  • Breakout Sessions! There were four concurrent breakout sessions on the following topic areas:
    • Post-Market Surveillance of Generic Drugs
    • Drug-Device Combination Products
    • In Vitro Bioequivalence Methods
    • Data Analysis and Model-Based Bioequivalence

FDA wants your input.

FDA seeks ideas on generic drug research topics from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties. You may submit your ideas for potential topics for the FY 2021 GDUFA Science and Research Priorities by submitting a comment on the public docket.

Workshop Recordings

Presentations

General Session

Title

Presenter

Keynote

Sally Choe, PhD, Director, Office of Generic Drugs

Workshop Introduction

Robert Lionberger, PhD, Director, Office of Research and Standards, Office of Generic Drugs

Postmarket Surveillance of Generic Drugs: Opportunities for GDUFA Research

Howard Chazin, MD, Director, Clinical Safety Surveillance Staff, Office of Generic Drugs

GDUFA Regulatory Science and Research on Generic Drug-Device Combination Products

Kimberly Witzmann, MD, Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs

GDUFA Regulatory Science and Research on In Vitro Bioequivalence Methods

Darby Kozak, PhD, Acting Deputy Director, Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs

Quantitative Methods and Modeling to Support GDUFA Regulatory Science Research Program

Liang Zhao, PhD, Director, Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs

Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development

Lei Zhang, PhD, Deputy Director, Office of Research and Standards, Office of Generic Drugs

Breakout Sessions

 

Breakout Session1: Post-market Surveillance of Generic Drugs Wrap-up Slides
Breakout Session 2: Combination Products Session Slides
  Risk Management Considerations for Drug-Device Combination Products Roisin Wallace
  Comparative Human Factors Studies Molly Story
Breakout 2 Wrap Up Wrap-Up Slides

Breakout Session 3: In Vitro Bioequivalence Methods

In Vitro Approaches as Alternatives to Clinical Studies for OINDPs – Andrew Cooper
  In Vitro Population Bioequivalence Parameters for Particle Size Distribution - Mark Liu
  Complex Formulations-Main Considerations – Theofanis Mantourlias
  Parenteral Products – DigiM
  Topical Products – Pina Dangelo
  Topical Products – Solaris
  Topical Products – Taro Canada
  Topical Products – Tergus
  Topical Products – Absorption Systems
  Topical Products – Diteba
  Topical Products – MedPharm
Breakout 3 Wrap Up Wrap-up slides

Breakout Session 4: Data Analysis and Model-Based Bioequivalence

Session Slides
  Modeling to Support Relaxation of Compositional/Microstructural Criteria to Qualify for Streamlined Bioequivalence Approaches – Charles DiLiberti
  Model Informed BE Expanding the Reach and Utility - Sid Bhoopathy
  Virtual Bioequivalence Requirements for Prudent Use of PBPK in Uncharted Territories - Amin Rostami
  Improved bioequivalence assessment through model-informed and model-based strategies - Andrew Hooker
  A Model- and Systems-Based Approach to Efficacy and Safety Questions Related to Generic Substitution - Stephan Schmidt
  Comments – Simulations Plus
Breakout 4 – Wrap Up Wrap-up slides

 

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