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11/21/2017

Australian researchers have identified exosomal microRNA molecules that appear to be biomarkers for multiple sclerosis and could help in developing new diagnostic assays. The findings were reported in the journal Scientific Reports.

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MD Magazine online
11/21/2017

Fourteen community organizations and health care provider associations will share a $1 million NIH grant to raise awareness and recruit a diverse cohort of volunteers for the All of Us precision medicine study. "It's been essential for us -- from the very start -- to have diverse voices at the table, weighing in on the best ways to engage and retain diverse communities in this program," said Dara Richardson-Heron, chief engagement officer for All of Us.

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Dara Richardson-Heron
11/21/2017

The FDA released an initial assessment of the agency's hiring and retention challenges that lay out a framework for building and maintaining a diverse workforce with specialized skills, Commissioner Scott Gottlieb writes. The agency will hold a public meeting to share the report's results and gather feedback from staff and the public, and it is launching a pilot program to "modernize and streamline hiring practices by using new IT tools and eliminating unnecessary processes," Gottlieb writes.

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FDA Voice blog
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Commissioner Scott Gottlieb
11/21/2017

Patients say health care providers increasingly engage them in decision-making, but more than 30% of patients responding to the survey said their provider did not always listen well, and more than 40% were dissatisfied with the amount of time their health care provider spent with them. The survey results, published in the Annals of Family Medicine, showed lower rates of shared decision-making among patients in poor health and when the patient's and provider's race or ethnicity differed.

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HealthDay News
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Annals of Family Medicine
11/20/2017

A group of 27 European states will decide today on where the new location of the European Medicines Agency will be after Brexit. They will select from 19 candidates.

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European Medicines Agency
11/20/2017

Amsterdam was chosen as the new site of the European Medicines Agency after three rounds of voting and a tiebreaking coin toss. More than 65% of EMA staff said they would be willing to relocate to that city or to Milan, which tied with Amsterdam in the final round of voting, according to the agency, which warned of permanent damage to the regulatory system if it did not have to sufficient staff to perform assessment and safety monitoring functions.

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Endpoints News
11/20/2017

The US FDA, European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency are working on a way to allow drugmakers to conduct a single development plan for antibiotics that will be accepted by all three agencies. Regulators from the three agencies had their third meeting in October and also agreed on the importance of studying antibiotics in pediatric patients.

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Regulatory Focus
11/20/2017

The FDA granted Grifols approval for its blood-based alpha-1 antitrypsin deficiency test for use with DNA extracted from a dry blood spot or a blood sample. The test is intended for the detection of 14 SERPINA1 mutations, which cause AAT deficiency, and enables simultaneous analysis of 192 samples per kit.

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FDA
11/20/2017

The first-in-human validation of Implandata Ophthalmic Products' next-generation Eyemate microsensor implant was performed at the University Eye Hospital in Germany. The device, which comes with the implantable microsensor and a hand-held device for implant powering and data readout, allows for continuous remote monitoring of intraocular pressure and reduces the size of incision for implantation from 4 mm to 2.7 mm.

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MassDevice (Boston)
11/20/2017

The FDA granted approval to Zydus Cadila's ethacrynate sodium for injection USP in 50 mg/vial, which is intended to reduce the swelling caused by congestive heart failure, cancer, liver and kidney disease and other disease conditions. The drug will be manufactured at the company's facility in Moraiya, Ahmedabad.

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PharmaBiz (India)
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FDA, Zydus Cadila