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

In this webinar, FDA provided an overview of the types of pre-ANDA meetings under GDUFA III, with specific focuses on changes and new features of pre-submission meetings. Presentations addressed how the redesigned scope and features of the pre-submission meeting may benefit preparation of ANDA submission and its regulatory assessment post submission.

Timestamps

01:01 – GDUFA III Redesigned Pre-Submission (PSUB) Meeting: Overview, Process, and What’s New?

18:00 – Pre-Submission Meetings: Scenario Discussion

01:07:05 – Panel Discussion

01:46:21 – Speaker Q&A Discussion

02:22:57 – Closing Remarks

Speakers:

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

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

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

Panelists:

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

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