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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

• Guidance For Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (October 2022)
• Draft Guidance for Industry: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (February 2023)
• 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)

CONTINUING EDUCATION

This webinar has been approved for 3.25 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim code.

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 webinar 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.
• pre-approved by 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.
• pre-approved by 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
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.