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Industry Can Notify FDA Drug Shortage Staff via CDER Direct NextGen
The Food and Drug Administration released a new technology platform for Industry to send drug shortage and supply notifications. CDER Direct NextGen allows Industry users to login, enter their shortage information, and submit to the FDA.
Industry can notify the FDA Drug Shortage Staff of new discontinuances, GMP issues, an 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.
Federal Register Notice: Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products 2016-2017 Influenza Season: Availability of Antivirals
- IV Fluid Shortage [ARCHIVED]
FDA takes two important actions on drug shortages Strategic Plan for Preventing and Mitigating Drug Shortages(PDF - 381KB)
FDA 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 firstname.lastname@example.org.
Drug Shortages Information
Strategic Plan for Preventing and Mitigating Drug Shortages(PDF - 381KB) Members of the Drug Shortages Task Force Executive Order -- Reducing Prescription Drug Shortages Graphic - A Drug Supply Chain Example Economic Analysis of the Causes of Drug Shortages (HHS)
- General Drug Shortages Questions and Answers
Current Drug Shortages Index
2016-2017 Influenza Season: Availability of Antivirals Managing Drug Shortages
FDA Drug Info Rounds Video
CBER-Regulated Products: Shortages and Discontinuations
- Six Month Check-Up: FDA's Work on Drug Shortages (5/3/2012)
- Obama Administration Takes Action to Reduce Prescription Drug Shortages, Fight Price Gouging (press release, 10/31/2011)
- Obama Administration Takes Action to Reduce Prescription Drug Shortages in the U.S. (fact sheet)
- Transcript: Drug Shortage Workshop (Sept. 26, 2011) (PDF - 2.6MB) [ARCHIVED]
Podcast: Drug Shortages Animal Drug Shortage Information Statement from FDA Commissioner Margaret Hamburg, M.D. and Assistant Secretary for Health Howard Koh, M.D., M.P.H. on Drug Shortages[ARCHIVED]
- Bedford Product Availability
DDI Webinar - Overview of U.S. Drug Shortages - April 29, 2014