sábado, 21 de enero de 2017

BSL-4 data quality course registration open | Emergency use final guidance | FDA requests comments

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January 19, 2017  |  FDA Medical Countermeasures Initiative Update

Instructor assists student into BSL4 protective suit

Course registration open

Achieving Data Quality and Integrity in Maximum Containment Laboratories
April 24-28, 2017 - National Institutes of Health, Bethesda, Maryland
FDA and the University of Texas Medical Branch, Galveston National Laboratory collaborate to provide an annual training course in how to meet Good Laboratory Practice (GLP) requirements in high and maximum biocontainment security level (BSL) laboratory facilities.
The course includes expert lectures and hands-on laboratory activities conducted in BSL-2 and BSL-4 training laboratories to emphasize the differences between biosafety levels, and the complexity of conducting laboratory activities in a BSL-4 environment.
FDA welcomes participants from government, industry, and academia, including international participants. Register by noon February 24, 2017.  
Related information

Emergency Use Guidance

On January 13, 2017, FDA published the guidance Emergency Use Authorization of Medical Products and Related Authorities
This guidance explains FDA’s general recommendations and procedures applicable to the authorization of the emergency use of certain medical products following the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). It addresses Emergency Use Authorizations (EUAs) and other MCM emergency use authorities (e.g., emergency dispensing orders and expiry dating extensions) provided by PAHPRA.
This finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces two guidance documents: Emergency Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions and Answers (April 2009).
Related information
EUA amendments
  • January 12, 2017 - CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) (CDC)
  • January 7, 2017 - xMAP® MultiFlex™ Zika RNA Assay (Luminex Corporation)
  • January 6, 2017 - RealTime Zika Assay (Abbott Molecular Inc.)
More information about EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, implemented in November 2016.
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Guidance and information for industry
  • FDA is reopening the comment period for the notification of public hearing, published in the Federal Register on September 1, 2016, concerning our comprehensive review of regulations and policies governing manufacturer communications regarding unapproved uses of approved or cleared medical products. Submit comments by April 19, 2017(January 19, 2017)
  • Draft guidance (biosimilars) - Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (PDF, 229 KB) - comment by March 20, 2017 (January 18, 2017)
  • Final guidance - Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus (PDF, 99 KB) - notifies blood establishments that FDA has determined Ebola virus to be a transfusion-transmitted infection (TTI) and provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country. (January 10, 2017)
  • FDA is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation. This order is effective February 13, 2017.
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