FDA chief Gottlieb says ‘holy grail’ flu shot is years off
March 28, 2018
By Neozene

The Centers for Disease Control and Prevention recently reported that flu immunizations have been about 36% effective in the U.S. this year, during a season that’s been particularly severe. No wonder experts are calling for alternatives, but the “holy grail”—a flu shot that fights any strain of virus—is still years away. At a Congressional committee hearing on Thursday, FDA commissioner Scott Gottlieb said “investing in—and working toward—the universal flu vaccine is crucial.” “Unfortunately, given where we are today in the development process, that reality is still many years off,” he

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AAMI Webinar on HFE Reports for Medical Device Manufacturers
March 15, 2018
By Neozene

A new webinar hosted by the Association for the Advancement of Medical Instruments (AAMI) will provide insights into preparing Human Factors Engineering (HFE) test plans and reports that existing regulatory guidance does not fully address. The AAMI webinar, “Writing Human Factors Plans and Reports,” has been developed to cover the lack of sample work products in HFE guidance documents issued by the US Food and Drug Administration and other regulators. The webinar takes place March 15, 2018 at 11am Eastern US time. Topics the webinar will cover include: HFE project plans

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