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BioWorld - Thursday, April 30, 2026
Home » Topics » Regulatory

Regulatory
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Regulatory actions for Aug. 14, 2020

Aug. 14, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo.
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Globe showing Asia-Pacific region

‘Made-in’ policies for medical devices spreading across Asia-Pacific region

Aug. 13, 2020
By Mark McCarty
The COVID-19 pandemic has exerted a massive effect on procedure volumes across the globe, but concerns over supply chains have prompted political officials in Washington to encourage domestic production of drugs. That approach is also in play in a number of nations in the Asia-Pacific region, said Sana Siddiqui of Decision Resources Group, who noted that Beijing wants hospitals in China to ensure that 70% of devices used there are domestically manufactured by 2025.
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Nanotechnology illustration

FDA works to leverage nanotech investment, better capacity for evaluation

Aug. 13, 2020
By Michael Fitzhugh
Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer.
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Will the lessons of COVID-19 be taken to heart this time?

Aug. 13, 2020
By Mari Serebrov
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
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Regulatory front for Aug. 13, 2020

Aug. 13, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for Aug. 13, 2020

Aug. 13, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular Therapeutics, Bayer, Hyperfine, Inmode, Osprey Medical, Quidel, RapidAI, Spectronrx.
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Regulatory actions for Aug. 13, 2020

Aug. 13, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Akeso, Antengene, Biomarin, Enzychem, Genentech, Hoth, Micurx, NS, Passage, Scholar Rock, TG.
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Hospital ICU, patient, monitor

Baxter nabs EUAs to address kidney injury in COVID-19 patients

Aug. 12, 2020
By Meg Bryant
The U.S. FDA has granted emergency use authorizations (EUAs) to Baxter International Inc. for its HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) during the COVID-19 pandemic. The two sets are intended for use with the company’s Prismaflex or Prismax CRRT monitors.
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Stock chart, compass

‘Bearing’ down: With the NRF2 persist after dicey FDA updates, Reata well enough left -olone?

Aug. 12, 2020
By Randy Osborne
Wall Street dinged Reata Pharmaceuticals Inc. earlier this week after mixed regulatory news on the nuclear factor erythroid-2 related factor 2 (NRF2) activators omaveloxolone for Friedreich’s ataxia (FA) and bardoxolone for Alport syndrome (AS), but the Plano, Texas-based firm stayed resolute, and its recent deal with Blackstone Life Sciences (BXLS) provides cause for optimism. Increased clarity on paths forward “debunks the bear-case view” of Reata, in the opinion of Jefferies analyst Maury Raycroft, who went as far as to say in a report that the stock “overreaction create[d] a buying opportunity.”
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Will the lessons of COVID-19 be taken to heart this time?

Aug. 12, 2020
By Mari Serebrov
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
Read More
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