lunes, 26 de septiembre de 2016

September 26, 2016 | FDA Medical Countermeasures Initiative Update

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September 26, 2016  |  FDA Medical Countermeasures Initiative Update

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Antimicrobial Resistance Information

Antimicrobial Resistance Diagnostics Challenge
A federal prize competition (sponsored by NIH and HHS ASPR) is calling for innovative ideas for rapid, point-of-care laboratory diagnostic tests to combat the development and spread of drug-resistant bacteria, a rising public health threat.
The Antimicrobial Resistance Diagnostic Challenge will award $20 million in prizes over all phases of the competition for new, innovative and novel laboratory diagnostic tests. The diagnostic tests being sought are those that identify and characterize antibiotic resistant bacteria and those that distinguish between viral and bacterial infections to reduce unnecessary uses of antibiotics, a major cause of drug resistance. More
International Regulatory Cooperation
On September 1-2, 2016, FDA participated in a meeting with the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA, Japan) to discuss regulatory approaches for the evaluation of antibacterial agents.
The EMA, PMDA, and FDA consider that a robust response to the problem of antimicrobial resistance must be multi-faceted and that the regulatory approach for the evaluation of antibacterial agents is only one element of the total response that is required to encourage and  accelerate new antibacterial drug development to meet patient needs. View the meeting summary (PDF, 34 KB)
Related Information
Image: Antibiotic resistance happens when bacteria change or mutate in a way that makes the drugs we prescribe less effective. Antibiotic resistance causes ~2,049,422 illnesses & 23,000 deaths annually in the U.S. The Challenge offers a pool of $20 million to spur innovation toward the creation of rapid, point-of-care diagnostics to identify bacterial infections. (Source: NIH)

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Zika EUA Updates

On September 23, 2016, FDA issued an EUA for emergency use of Vela Diagnostics USA, Inc.’sSentosa® SA ZIKV RT-PCR Test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine. Test results are for the identification of Zika virus RNA.  Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. Additional technical information, including Instructions for Use and fact sheets
On September 21, 2016, in response to CDC's request to amend the Trioplex Real-time RT-PCR Assay issued on March 17, 2016, FDA granted the CDC-requested amendments, including claims for detecting Zika virus, Dengue virus, and chikungunya virus RNAs in whole blood (EDTA) specimens.Additional technical information, including updated Instructions for Use and fact sheets

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