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  4. A Deep Dive: GDUFA III Scientific Meetings - 05/15/2023
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Virtual | Virtual

Event Title
A Deep Dive: GDUFA III Scientific Meetings
May 15, 2023

Date:
May 15, 2023
Time:
1:00 PM - 4:30 PM ET

 

Topic & Presentations

Speakers

A Deep Dive: GDUFA III Scientific Meetings

 

A Deep Dive: GDUFA III Scientific Meetings
Introduction.pdf

Lei Zhang, PhD
Deputy Director
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)

GDUFA III Redesigned Pre-Submission
(PSUB) Meetings.pdf

Karen Bengtson
Supervisory Regulatory Health Project Manager
ORS|OGD|CDER

A Deep Dive into the New GDUFA III Meeting: Post-Complete Response Letter (CRL) Scientific Meeting.pdf

Tao Bai, PhD
Senior Advisor
Office of Bioequivalence (OB)
OGD|CDER

GDUFA III Product-Specific Guidance (PSG)
Teleconferences.pdf

Caliope Sarago, MHSA
Senior Regulatory Health Project Manager
ORS|OGD|CDER

GDUFA III Product-Specific Guidance (PSG) Meetings.pdf

Hee Sun Chung, PhD
Lead Pharmacologist
Division of Bioequivalence I (DB I) OB|OGD|CDER

Q&A Discussion Panel

The above-mentioned speakers including:

Rob Lionberger, PhD
Director
ORS|OGD|CDER

Partha Roy, PhD
Director
OB|OGD|CDER

Pinaki Desai, PhD
Senior Biologist
Office of Lifecycle Drug Products (OLDP)
Office of Pharmaceutical Quality (OPQ)
CDER

John Ibrahim, PharmD, BCPS
Associate Director of Regulatory Affairs
Office for Regulatory Operations (ORO)
OGD|CDER

David Coppersmith, JD
Regulatory Counsel
Division of Policy Development (DPD)
Office of Generic Drug Policy (OGDP)
OGD|CDER

Closing Remarks

Rob Lionberger, PhD
Director
ORS|OGD|CDER

Agenda

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ABOUT THIS WEBINAR

On September 30, 2022, the Generic Drug User Fee Amendments (GDUFA) were reauthorized with provisions that are in effect from October 1, 2022, through September 30, 2027 (GDUFA III). In the GDUFA III commitment letter, FDA has made a number of enhancements or changes to the existing generic drug program’s pre-ANDA and ANDA process as it relates to scientific meetings that help provide clarity to current and prospective applicants looking to develop new generic drug products.

The goals of these meetings are to:

  • clarify regulatory expectations for prospective applicants early in product development
  • assist applicants in developing more complete, quality submissions
  • promote a more efficient and effective ANDA assessment process
  • reduce the number of assessment cycles required to obtain ANDA approval
  • enhance communication
  • provide targeted, robust advice as applicants work to meet the standard for ANDA approval

This webinar will take an in-depth look into the following three types of scientific focused meetings offered under GDUFA III:

  • Pre-Submission Meetings
  • Post-Complete Response Letter (CRL) Scientific Meetings
  • Product-Specific Guidance (PSG) Teleconferences and Pre- and Post-submission PSG Meetings

LEARNING OBJECTIVES

  • Provide an in-depth look into the enhancements and new features of these meetings
  • Describe how and when to utilize these meetings to support generic drug development
  • Provide clarification and best practices in meeting request and conduct

INTENDED AUDIENCE

This webinar is for members of the generic drug industry, including current and potential applicants who are interested in submitting an application for a generic drug, regulatory reviewers for generic drug development and assessments, consultants focused on bioequivalence, clinical research coordinators, and foreign regulators.

FDA RESOURCES

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