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Appendix 1: FDA Offices Engaged in Mitigating Drug Shortages

Table of Contents: A Review of FDA’s Approach to Medical Product Shortages

Center for Drug Evaluation and Research

Drug Shortage Program: Facilitates prevention and resolution of shortages by collaborating with stakeholders involved in or affected by drug shortages, including FDA experts, industry, and external stakeholders.  Also provides drug shortage information to the public and conducts outreach to health-care professional organizations, patient groups, and other stakeholders.

Office of New Drugs: Assesses whether a particular drug is medically necessary and assesses the risks associated with continued distribution if there are quality concerns.

Office of Pharmaceutical Science (Office of Generic Drugs) and Office of New Drug Quality Assurance: Expedites review and pre-approval inspections of applications for new manufacturing sites, suppliers, production lines, and other changes related to addressing or preventing a shortage of a medically necessary drug.  Facilitates resolution of regulatory and scientific issues related to the drugs in shortage, including issues that involve Chemistry, Manufacturing, and Controls issues.

Office of Compliance: A dedicated Recalls Coordination Branch functions as coordinator between the Office of Compliance and DSP.  OMPQ in the Office of Compliance works with firms to help resolve manufacturing/quality issues. May utilize flexibility through regulatory discretion to address shortages and mitigate risks to patients.  Can also facilitate expedited inspections or develop options related to inspections and reinspections, and initiate, facilitate, and monitor importation plans.

Office of the Commissioner

Office of Regulatory Affairs: As the lead office for FDA field activities, provides FDA leadership on imports, inspections, and enforcement policy.  ORA inspects regulated products and manufacturers, conducts sample analysis on regulated products, and reviews imported products offered for entry into the United States.

Next Section: Appendix 2: Comparison of Medical Product Shortage Activities in Selected FDA Centers