Drug Shortages

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FDA works to help relieve the IV fluid shortages in wake of Hurricane Maria
[11/14/2017] The U.S. Food and Drug Administration is actively working with drug manufacturers to address critical shortages of IV fluids aggravated by Hurricane Maria’s impact on Puerto Rican drug manufacturing facilities. (Read full CDER statement)

News for Drug Manufacturers/Applicants: Industry Can Notify FDA Drug Shortage Staff via CDER Direct NextGen Collaboration Portal

The Food and Drug Administration released a new technology platform for Industry (drug manufacturers/applicants) to send drug shortage and supply notifications. CDER Direct NextGen allows Industry users to login, enter their shortage information, and submit to the FDA. *Please note: 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 via the CDER Direct NextGen Collaboration Portal. This online tool helps minimize manual data entry and will ultimately allow for better drug shortage monitoring and mitigation.

To request a login visit: https://edm.fda.gov

If you have any questions, please contact:

Upgraded Drug Shortages app for Android devices adds alert feature

The Food and Drug Administration released Drug Shortages 2 mobile application for Android devices. Android device users are able to receive notifications when there is new or updated information about a shortage of a drug product or about a drug within selected therapeutic categories.

Designed for Android devices, Drug Shortages 2 sends alerts when the Agency adds or updates shortage information about a drug product or about a drug within selected therapeutic categories. We are currently working on notifications for the iOS version of the Drug Shortage mobile app, which will be available soon.

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Download the Drug Shortages Mobile Application

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Drug ProductionFDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. The agency works closely with manufacturers of drugs in short supply to communicate the issue and to help restore availability. FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage.

The majority of drug shortage information is provided to FDA by manufacturers. Communication between FDA and the public is an essential component of preventing and mitigating drug shortages.  To ensure information is current, FDA appreciates all information and updates about shortages provided by manufacturers.  Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov.

Page Last Updated: 06/15/2018
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