---

---

Workshop Location 

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)

Summary

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.

Meeting Agenda

• Agenda (PDF - 232 KB)

Registration

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. 

Accessibility 

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. 

Contact 

For additional details, contact the FDAs CDER/OND/Public Meeting Team at ONDPublicMTGSupport@fda.hhs.gov. 

---