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  4. Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - 04/10/2024
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Conference | Mixed

Event Title
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access
April 10 - 11, 2024


Date:
April 10 - 11, 2024
Day1:
- ET
Day2:
- ET

Location: Hybrid:

Attend In Person or Online
Click HERE for Onsite Attendance Information Details

Agenda

Weds, April 10   Thurs, April 11

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Keynote Speakers

Iilun Murphy headshot photo

Iilun Murphy, MD
Director
Office of Generic Drugs
Center for Drug Evaluation and Research (CDER) | FDA

Susan Rosencrance Headshot Photo

Susan Rosencrance, PhD
Acting Deputy Director for Science
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA

ABOUT THIS EVENT

The Generic Drugs Forum is an annual, two-day event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the pre-ANDA program and ANDA assessment program. The goal of the forum is to provide practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.

This year’s theme is Regulatory Considerations to Enhance Generic Drug Access, and our agenda will address essential regulatory information on how to engage with the Agency and gain information about ANDA development and ANDA assessment. Presentations will focus on resources, best practices, common deficiencies, and opportunities to engage with the Agency from pre-ANDA to post-approval submissions.

INTENDED AUDIENCE

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:

  • Are involved in generic drug development
  • Are submitting or have submitted a generic drug application, amendment, or supplement

TOPICS COVERED

  • Controlled Correspondence
  • Pre-ANDA Submissions and Meetings
  • ANDA Submissions, Assessments, and Meetings
  • Post-Approval Submissions
  • Other Considerations

Agenda

FDA RESOURCES

 
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