Meeting of Interest! CDER Public Workshop - Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment

About the Workshop

The Food and Drug Administration is announcing the following public workshop entitled "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.

The public workshop will be held on August 21, 2018 from 9:00 AM until 12:00 PM.

Workshop Location

The public workshop will be held in the White Oak Great Room at the FDA Headquarters, 10903 New Hampshire Avenue, 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. Click here for parking and security information

Additional Details

This meeting will be accessible both in-person and through webcast (see Registration).

A link to join the webcast will be sent 2 days before the meeting day. Onsite registration will be available.

Meeting Agenda

This session will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular end-points. Click here for the full agenda

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