martes, 12 de abril de 2016

Protecting the U.S. from emerging public health threats (report) | New EUA guidance | Zika updates

FDA Medical Countermeasures Initiative Update

FDA MCMi program update report cover - FY15

Learn how FDA helps protect the U.S. from emerging public health threats

April 12, 2016 - Today FDA issued the annual Medical Countermeasures Initiative (MCMi) program update report for our fifth year of operations.
FDA continues our ongoing work to advance the development and availability of medical countermeasures to protect against chemical, biological, radiological, and nuclear (CBRN) threats.
This report covers these activities including medical countermeasure-related regulatory science, and legal and policy actions. 

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Emergency Use Authorization - New Draft Guidance

In April 2016, FDA issued a new Draft Guidance for Industry and Public Health Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Although you can comment on any guidance at any time, to ensure FDA  considers your comment on this draft guidance before beginning work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 3, 2016

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FDA and Brazil cooperate to address Zika virus

On April 11, 2016, FDA and the Brazilian Health Regulatory Agency (ANVISA) issued a joint statement of continued cooperation to address the public health emergency presented by the Zika virus disease outbreak in the Americas. 

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News updates

  • New! April 13, 2016: FDA will join other public health experts in a Zika Twitter chat hosted by Reuters, 2:00 - 3:00 p.m. ET, #ReutersZika 
  • April 19-22, 2016: Preparedness Summit disclaimer icon (Dallas, TX), hosted by the National Association of County and City Health Officials (NACCHO) (fee) - includes a Medical Countermeasures Link workshop disclaimer icon to provide federal updates for state strategic national stockpile and local MCM coordinators. New! FDA will also present at the late-breaking Zika session on April 19. 
View more events on the frequently updated MCMi News and Events page
In case you missed it:
  • In direct response to requests from the public, FDA has extended the comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoesAedes aegypti mosquitoes are known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya. The comment period will now end on May 13, 2016.
  • FDA is sharing an interactive tool for mobile health app developers created by the Federal Trade Commission (FTC) in collaboration with the FDA, the Office of the National Coordinator for Health IT (ONC) and HHS’s Office of Civil Rights (OCR). The purpose of the tool is to help developers whose apps collect, create or share consumer information determine which federal laws apply to their products. (April 5, 2016)

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