Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment
August 20, 2018
The Food and Drug Administration hosted a public workshop on "Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.”
The purpose of the public meeting/public workshop is to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight potential end-points that can be used in both nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for drugs impacting auditory and vestibular functions. This session will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular end-points.
Meeting Date and Time
August 21, 2018
9:00 A.M. to 12:00 P.M.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Room 1503, Section A)
Silver Spring, MD 20993-0002
The entrance for public meeting participants (non-FDA employees or contractors) 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.
- Federal Register Notice
- Public Meeting Agenda (will provide within 5 – 7 days of meeting)
- Meeting Presentations
- Heather Fitter, M.D., Clinical Regulatory Perspectives on Drug Developmentin CDER for Oto-and Vestibular Disorders. (PDF - 118KB)
- Nandkumar, Srinivas "Nandu", CDRH Regulation of Otologic and Vestibular Devices (PDF - 353KB)
- Toscano, Christopher D., Nonclinical Assessment of Otic & Vestibular Toxicity: A Regulatory Perspective (PDF - 190KB)
- Barker, Jessica, Toxicology Studies: Part 1, Neurological Evaluation of Vestibular and Auditory Function (PDF - 36,752KB) (page 16 video not included)
- Schafer, Ken, Histopathologic Evaluation of the Ear in Nonclinical Safety Studies. (PDF - 3,941KB)
- Fitzgerald, Tracy. Otic and Vestibular Electrophysical Measurements. (PDF - 1,383KB)
For information regarding this meeting, contact Deepa B. Rao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4235, Silver Spring, MD 20993, Deepa.Rao@fda.hhs.gov or Christopher D. Toscano, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4145, Silver Spring, MD 20993, Christopher.Toscano@fda.hhs.gov.