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FDA Intra-Agency Neurology Working Group

Background

Neurology products regulated by the Food and Drug Administration, comprising drugs, devices, biologics, and combination products, are a diverse group of products aimed at advancing patient care in a number of disease areas for which the unmet therapeutic need is great. Some diseases affect large number of patients, such as Alzheimer’s Disease and Parkinson’s Disease, while other neurological diseases affect smaller numbers of patients, both with devastating consequences for patients and their families.

Goal

To improve neurological disease communication across FDA, as a means to:

• serve as a forum for information exchange on leading-edge developments,
• enable sharing of technical and regulatory expertise,
• provide for greater consistency of review standards and processes across FDA,
• expand patient advocate involvement in FDA neurological disease-related review and decision-making to include Parkinson's disease, Alzheimer's disease, and other neurological diseases as agency resources allow
• improve FDA’s ability to facilitate development of medical products to diagnose and treat serious neurological diseases.

Chairpersons

Dr. Celia Witten, CBER/Director, Office of Cellular, Tissue, and Gene Therapy Dr. Robert Temple, Director, CDER/Office of Drug Evaluation I, Office of Medical Policy

Members

Review staff, supervisory reviewers, senior officials, and project managers, as designated from the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH).

Meeting Frequency and Agenda

Meetings scheduled every month by Liza Saavedra, 301-827-5102, liza.saavedra@fda.hhs.gov (or Colleen Locicero, 301-796-1114, colleen.locicero@fda.hhs.gov).

Standing Agenda items to include:

1. Policy Development (Guidances, Workshops, AC Meetings)
2. Critical Path Projects
3. Significant review projects (major investigational/marketing applications under review, marketing approvals, studies of interest, etc.)
4. Neurology Roundup update
5. Upcoming Neurology-related meetings
6. Patient advocate involvement and OSHI updates

Reports will be requested from each group in advance of meetings.

Points of Contact

• The contact point for patient advocacy organizations will be OSHI (david.banks@fda.hhs.gov, 301-827-4460).
• Medical product sponsors will continue to work with the medical product review divisions with review responsibility for their application.
• Industry or academic groups who wish to propose general issues for consideration by the working group, for issues that cannot be dealt with at the Division or Center level, should contact Colleen Locicero (colleen.locicero@fda.hhs.gov 301-796-1114).

Status Report

OSHI will draft an annual report for issuance from the group to the Commissioner, and for public release, discussing the work and accomplishments of the group.

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