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  4. Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval - 05/09/2024
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Virtual | Virtual

Event Title
Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval
May 9, 2024

Date:
May 9, 2024
Time:
1:00 p.m. - 3:30 p.m. ET

Topic & Presentations

Speakers

Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval

 

GDUFA III Redesigned Pre-Submission (PSUB) Meeting: Overview, Process, and What’s New?

Karen Bengtson
Supervisory Regulatory Health Project Manager
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD) | CDER

Pre-Submission Meetings: Scenario Discussion

Yan Wang, PhD
Lead Pharmacologist
Division of Therapeutic Performance I
ORS | OGD | CDER

and

Eleftheria Tsakalozou, PhD
Senior Pharmacologist & Acting Team Lead
Division of Quantitative Methods and Modelling
ORS | OGD | CDER

Panel Discussion

Pahala Simamora, PhD
Division Director
Division of Product Quality Assessment (DPQA IX)
Office of Product Quality Assessment II (OPQA II)
Office of Pharmaceutical Quality (OPQ)

Partha Roy, PhD
Director
Office of Bioequivalence (OB)
OGD | CDER

William (Bill) Chong, MD
Director
Office of Safety and Clinical Evaluation (OSCE)
OGD | CDER

Robert Lionberger, PhD
Director
ORS|OGD|CDER

Speaker Q&A Discussion

Karen Bengtson, Yan Wang, Eleftheria Tsakalozou, Pahala Simamora, Partha Roy, William (Bill) Chong, and Robert Lionberger

Closing Remarks

Robert Lionberger

 

AGENDA

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug development and regulatory activities is to provide constructive feedback on proposed generic development plan and prospective submission prior to an Abbreviated New Drug Application (ANDA) submission via meetings.

In this webinar, FDA will provide an overview of the types of pre-ANDA meetings under GDUFA III, with specific focuses on changes and new features of pre-submission meetings. FDA will:

  • Address how the redesigned scope and features of the pre-submission meeting may benefit preparation of ANDA submission and its regulatory assessment post submission
  • Discuss a hypothetical case to illustrate how to prepare a successful pre-submission meeting request
  • Host a panel discussion on topics pertinent to the generic drug industry
  • Answer questions during live Q&A sessions with FDA experts

INTENDED AUDIENCE

  • The generic drug industry, consultants, regulatory affairs professionals, or contractors, with an emphasis on those who are involved in generic drug development, plan to submit an ANDA, or are in the process of submitting an ANDA or have submitted an ANDA
  • Regulatory reviewers for generic drug development and assessments

TOPICS COVERED

  • Overview of scope and new features of pre-submission meetings under GDUFA III
  • Benefits of pre-submission meetings
  • How and when to utilize pre-submission meetings
  • Preparation of pre-submission meeting request

AGENDA

FDA RESOURCES

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