sábado, 27 de agosto de 2016

FDA advises testing for Zika virus in all donated blood in the U.S.

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August 26, 2016  |  FDA Medical Countermeasures Initiative Update

Revised guidance - FDA advises testing for Zika virus in all donated blood in the U.S.

FDA now recommends testing all U.S. blood donations for Zika virus

As a further safety measure against the emerging Zika virus outbreak, on August 26, 2016, FDA issued revised guidance for reducing the risk of Zika virus transmission by transfusion of blood and blood components. FDA now recommends that all blood donations (Whole Blood and blood components) in the U.S. and its territories:
  • Be tested with an investigational donor screening test for Zika virus,
  • Be tested with a licensed screening test when available (no licensed screening tests are available at this time), or
  • Be treated with an FDA-approved pathogen reduction device. (Currently, such technologies are available only for platelets and plasma.) 
Testing of donated blood is already underway in Florida and Puerto Rico, and it has shown to be effective in identifying donations infected with Zika virus.
Related Information

Guidance and information for industry

  • FDA is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. As part of proposed changes to this rule, FDA seeks comment on the impact of expanding part 58 to include coveredAnimal Rule studies, and what other changes to the regulations, beyond amending the scope and definitions, are needed to address issues unique to covered Animal Rule studies. Comment by November 22, 2016(August 24, 2016) 


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