miércoles, 31 de enero de 2018

Register now for data quality in BSL-4 labs course | Learn about biosimilars | Auto-injector EUA update

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update
Course attendees participate in lectures and hands-on activities during previous courses.

Register now!
Course designed for researchers who conduct studies to support approval under the Animal Rule
Early registration is recommended, as this course quickly fills to capacity. FDA sponsors this course as
part of our work to advance the development and availability of medical countermeasures. There is no
registration cost. Register by February 16, 2018.

Related links: 
Image: Course attendees participate in lectures and hands-on activities during previous courses. More course photos are available on Flickr
New biosimilar resources
FDA approves a biosimilar after rigorous evaluation. All biosimilars meet FDA's rigorous standards for approval, are manufactured in FDA-licensed facilities, and are tracked as part of 
post-market surveillance to ensure continued safety.
Have questions about biosimilars? Check out FDA’s new biosimilar resources – they include biosimilar definitions, information about prescribing them, and details on their rigorous approval standards. 
Image: FDA approves a biosimilar after rigorous evaluation. All biosimilars meet FDA's rigorous standards for approval, are manufactured in FDA-licensed facilities, and are tracked as part of post-market surveillance to ensure continued safety.
EUA updates
Emergency Use Authorization, with emergency sign
EUA amendment
  • January 24, 2018:  In response to CDC's request, FDA concurred (PDF, 33 KB) with amendments to the Rafa Atropine Auto-Injector EUA (1) to clarify that the authorized product (0.5 mg, 1 mg, and 2 mg) may be administered through clothing, and (2) for changes to certain Rafa-planned manufacturing processes. The Rafa Atropine Auto-Injector was initially authorized for emergency use for initial treatment of nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning in April 2017. Additional information, including updated fact sheets
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.
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 July 24, 2017.
Events
Information for industry More: MCM-Related Guidance by Date
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