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Department of Health and Human Services
Discretionary Advisory Committee on Heritable Disorders in Newborns and Children

Twenty Fourth Meeting

May 5-6, 2011: FDA policies and procedures relevant to individuals with rare, heritable disorders; public health framework for hospital-based newborn screening

Agenda (PDF - 81 KB)

Meeting Minutes (PDF - 908 KB)

Audio Archives and Transcripts

Presentations

Public Health Framework for Hospital-based Newborn Screening (PDF - 57 KB)
Nancy S. Green, MD

FDA Policies and Procedures Relevant to Individuals with Rare Heritable Disorders (PDF - 2 MB)
Jerry Vockley, M.D., Ph.D.

Expanded Access to Investigational Drugs-the Road to Marketing (PDF - 93 KB)
Anne Pariser, M.D.

Critical Drug Shortages for Necessary Medications (PDF - 2 MB)
FDA

Overview of Device Regulation (PDF - 3 MB)
Kellie B. Kelm, Ph.D.

Lab Committee Report (PDF - 24 KB)
Jerry Vockley, M.D., Ph.D.

Education and Training Subcommittee Report (PDF - 304 KB)
Tracy Trotter

Hyperbilirubinemia Evidence Review (PDF - 1 MB)
John Patrick T. Co, MD, MPH, James M. Perrin, MD

SACHDNC SCID Report Presentation (PDF - 438 KB)
Amy Brower, PhD

The Committee/ES Annual Report to Congress (PDF - 657 KB)
Alissa Johnson

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