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New draft guidance on extending expiration dates of doxycycline in stockpiles | Register now for the FDA Science Forum + more May events

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May 4, 2017  |  FDA Medical Countermeasures Initiative Update

Wooden pallets containing public health emergency supplies inside the CDC's Strategic National Stockpile

New draft guidance for anthrax emergency preparedness and response

On April 25, 2017, FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF, 226 KB). This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. Read more
Although you can comment on any guidance at any time, to ensure that FDA considers your comment before finalizing this guidance, submit either electronic or written comments within 60 days of publication of the Federal Register notice, by June 26, 2017.
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Image: Captured inside the Strategic National Stockpile (SNS), Ebola Kit Building, this image depicts wooden pallets, which supported stacks of boxes containing personal protective equipment (PPE) items. CDC’s SNS is the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local supplies to run out. The stockpile ensures the right medicines and supplies are available when and where needed to save lives. (Credit: CDC/Kamelya Hinson, Strategic National Stockpile Logistics Team)
Learn about FDA's research at the FDA Science Forum

Register for the FDA Science Forum

May 31 - June 1, 2017
FDA White Oak Campus, Silver Spring, MD and webcast
Learn about FDA's cutting-edge research, how the Agency applies new science and technology in regulatory decision-making, and discover how you can collaborate with FDA. The Forum includes presentations about medical countermeasure (MCM)-related research on May 31, as part of Concurrent Session 2.
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EUA Updates

Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.
EUA amendment
  • April 12, 2017: Aptima® Zika Virus assay (Hologic, Inc.)
More information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated in November 2016.
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