The National Institutes of Health (NIH) has submitted interim corrective action plans to the U.S. Food and Drug Administration (FDA) to address problems with sterile manufacturing processes identified in its Pharmaceutical Development Section (PDS) and deficiencies of lesser significance in its pharmacy announced on June 4, 2015. NIH takes this issue very seriously and senior leadership took swift action to ensure the safety of research participants. As corrective action is taken to remedy the situation, NIH will continue to take every measure to protect patients and provide access to needed treatments.
As part of the plan, NIH will hire a contracting firm experienced in Current Good Manufacturing Practice (CGMP) regulations and procedures. The firm will provide a full evaluation of the PDS operations and make recommendations for improvement and for addressing all FDA concerns. NIH will also establish an external group of advisors with expertise in CGMP-facility management, clinical research, engineering and regulatory requirements to consider the recommendations of the contractor and oversee the implementation of the corrective actions. The plan outlines an aggressive timeline to achieve key milestones by the end of September 2015.
NIH Interim Corrective Action Plan PDS (PDF - 942KB)
NIH Interim Corrective Action Plan Pharmacy (PDF - 264KB)
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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