- November 30, 2023 - December 1, 2023
- - ET
- - ET
- Organized By:
FDA White Oak Campus
Building 31, Conference Center, The Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20993
Organized by: CDER’s Office of New Drugs
Host Office Division: University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA)
The purpose of this public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
Goals and Objectives
Advancing the Development of Pediatric Therapeutics Workshop on Drug Dosing in Pediatric Patients with Renal Impairment.
- Agenda (PDF - 232 KB)
Please register online at Eventbrite
Topics for Discussion
Please check back for finalized topics for discussion
Visiting FDA Campus
Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.
Virtual Attendance Information
This meeting will be hybrid. The Zoom link will be provided to all registered attendees in a calendar invite the day before the meeting.
Food and Drink
Public meeting attendees may bring their own food and drink. However, the FDA cannot guarantee the use of a refrigerator or microwave. Light refreshments and sandwiches are often available for purchase at public meetings. Restaurants near the FDA White Oak campus are available, before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.
The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 7 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.
For additional details, contact the FDAs CDER/OND/Public Meeting Team at ONDPublicMTGSupport@fda.hhs.gov.