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  1. Drug Safety and Availability

Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages.

In October 2019, FDA issued a report, “Drug Shortages: Root Causes and Potential Solutions” that attempts to identify root causes and offer recommendations to help prevent and mitigate drug shortages. The recommendations were based on insights gleaned from public and private stakeholders at a November 2018 Drug Shortages Task Force Public Meeting, a docket for comments, and listening sessions with stakeholders, as well as FDA data analysis and published research.   

Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov.

Drug Shortages Database

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Influenza Season 2018-2019

Availability of Antiviral Medications (PDF - 51KB) [Updated 4/5/2019]

Statement from FDA Commissioner Scott Gottlieb, M.D.

FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

For Industry: Send FDA Drug Shortage and Supply Notifications

Industry can notify FDA Drug Shortage Staff via CDER Direct NextGen Portal.

This portal is intended ONLY for drug manufacturers/applicants. Industry can notify the FDA Drug Shortage Staff of new discontinuances, GMP issues, increase in product demand, recalls, supply interruptions, or other events.  If you have any questions, please contact: drugshortages@fda.hhs.gov.

FDA Drug Shortages Mobile App

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  Android App App FDA Drug Shortages App

Receive notifications when there is new or updated information about a drug product shortage or a drug within selected therapeutic categories.

 



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