LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection.
The U.S. FDA’s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP’s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic.
PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities.
Denver-based Biointellisense Inc. has unveiled Biobutton, a coin-sized, disposable medical device that measures continuous temperature and other vital signs for 90 days. The device, coupled with HIPAA-compliant data services, permits remote data capture and continuous multiparameter monitoring of temperature, respiratory rate and heart rate at rest, body position, sleep and activity state.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Bedfont Scientific, Philosys, Rutgers Clinical Genomics Laboratory, Spectrum Solutions, University of Kentucky.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Software, Aptar, Atrion, Beroni, Bioreference Laboratories, Cryolife, Fullerton Health, Guardant Health, Helius Medical Technologies, Livinguard, Opko Health, Orthofix, Twist Bioscience, United Health Products.
In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses.
Several companies have reported quarterly results over the past couple of days, and those offering testing for COVID-19 have seen impressive numbers. Standing out was San Diego-based Quidel Corp., whose numbers caught the attention of William Blair’s Brian Weinstein. Indeed, its $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza.
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