martes, 2 de agosto de 2016

Zika Emergency Use Authorizations and blood collection advice | New fluoroquinolone antibiotics warnings

FDA Medical Countermeasures Initiative Update

A Zika virus researcher at the NIAID Vaccine Research Center prepares samples. Credit: NIAID, via Flickr

Zika diagnostic Emergency Use Authorizations (EUAs)

An EUA is a tool FDA can use to allow the use of certain medical products for emergencies based on scientific data.  The U.S. Secretary of Health and Human Services declared in February 2016 that circumstances exist to allow the emergency use of authorized diagnostic tests for Zika virus infection. FDA has issued 7 EUAs for Zika diagnostic tests, as of July 29, 2016.
EUAs issued in the last two weeks:
  • July 19, 2016 - Zika Virus Real-time RT-PCR Test (Viracor-IBT), Viracor-IBT Laboratories, Inc.
  • July 29, 2016 - VERSANT® Zika RNA 1.0 Assay (kPCR) Kit, Siemens Healthcare Diagnostics, Inc.

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Image: A Zika virus researcher at the NIAID Vaccine Research Center prepares samples. Learn more about NIAID's Zika virus research. Credit: NIAID, via Flickr

FDA advice to blood collection establishments on non-travel related cases of Zika virus in Florida

July 27, 2016 - The Office of the ‎Florida Department of Health State Surgeon General has announced that it is conducting an epidemiological investigation into a number of non-travel related cases of Zika virus in Miami-Dade and Broward Counties. These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States. Miami-Dade County and Broward County are adjacent counties in South Florida.

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FDA updates warnings for fluoroquinolone antibiotics

On July 26, 2016, FDA approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.

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FDA issues draft guidance on the use of real-world evidence to support regulatory decision-making for medical devices

On July 26, 2016, FDA released a draft guidance document on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (PDF, 541 KB). 

Real-world data, which are collected from sources outside of traditional clinical trials, can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients.  The draft guidance gives generalized examples taken from actual uses of real-world data as valid scientific evidence for various regulatory decisions.
This draft guidance is a cornerstone of our strategic priority of creating a national evaluation system for medical devices.  That system would build on and leverage the vast amount of data and information collected during the treatment and management of patients.
Submit comments on this draft guidance by October 25, 2016If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or

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