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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 PM - 3:30 PM ET


AGENDA

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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 GDFUA 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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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