May 9, 2024
Enroll in the Pre-Submission Meetings Course
Enroll in the Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval course to access all lessons and resources.
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Presentations
About This Course
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
Resources
- Guidance For Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (October 2022)
- GDUFA III Reauthorization
- GDUFA III Enhancement to the Pre-ANDA Program
- ANDA Assessment Program – GDUFA III Performance Goals and Program Enhancements
- MAPP 5240.10: Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes (April 2022)External Link Disclaimer
- SBIA Webinar – A Deep Dive: GDUFA III Scientific Meetings