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

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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

FDA RESOURCES

Content current as of:

11/22/2024

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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