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Regulatory
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Intravitreal Eylea approved for neovascular glaucoma

March 26, 2020
Hand holding FDA blocks

Test developers frustrated by FDA’s resistance to at-home testing

March 25, 2020
By Mark McCarty
The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
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3-25-Align-itero-element-5d.png

FDA OKs Align Technology’s Itero Element 5D dental scanner

March 25, 2020
By Meg Bryant
San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
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Regulatory front for March 25, 2020

March 25, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Gilead abandons orphan drug designation for COVID-19 drug

March 25, 2020
By Mari Serebrov
Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
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Regulatory front for March 25, 2020

March 25, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More

Japanese approval of Tepmetko for advanced NSCLC with METex14 skipping alterations

March 25, 2020

Policy advocates propose measures for clinical disruptions in China

March 24, 2020
By Elise Mak and Cornelia Zou
BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks.
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Architectural pillars

Regulatory front for March 24, 2020

March 24, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: 340B Health, Department of Health and Human Services, FDA, Health Resources and Services Administration, Institute for Clinical and Economic Review, Medicines and Healthcare products Regulatory Agency.
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Regulatory front for March 24, 2020

March 24, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More
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