The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).” The purpose of this public workshop is to have a forum for dialogue with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes and to identify additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease.
The ultimate purpose of identifying and qualifying these outcomes for regulatory purposes would be to continue to support the development of novel therapies that directly address the needs of diabetes patients living with the disease. There will be an opportunity for questions and answers following each presentation.
DATE, TIME AND LOCATION:
August 29, 2016, from 9:00 a.m. to 5 p.m.
FDA’s White Oak campus, 10903 New Hampshire Ave., Building 31 (The Great Room A, B, and C), Silver Spring, MD 20993. 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 Meetings at the FDA White Oak Campus.
For further information:
contact Dr. Francis Kalush, Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
Registration: There is no registration fee to attend the public workshop. Early registration is recommended because seating is limited, and registration will be on a first-come, first-served basis. There will be onsite registration. Persons interested in attending this workshop must register online at Meetings, Conferences, & Workshops (Drugs) before August 26, 2016. The link for registration is: https://www.eventbrite.com/e/diabetes-outcome-workshop-tickets-24993884381
- Introductions and Regulatory Perspective Session
- Patient and Patient Advocacy Perspective Session
- Industry Experience in Outcome Measures for Diabetes Session
- Lessons Learned, with Stakeholders Representatives- Round Table Discussion
Transcript: A transcript of the workshop will be available for review at regulations.gov approximately 30 days after the workshop.