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
When:from Wednesday, April 10, 2024 8:30 AM
thru Thursday, April 11, 2024 5:00 PM
