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Home » Topics » Regulatory

Regulatory
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J&J’s $5B opioid settlement is on

Feb. 28, 2022
Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. reported that they have a sufficient level of participation to move forward with a $5 billion nationwide settlement to resolve opioid-related claims and litigation by states, cities, counties and other government subdivisions in the U.S.
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Aortic aneurysm illustration

US FDA eyes real-world surveillance for devices indicated for repair of AAAs

Feb. 28, 2022
By Mark McCarty
There are several devices on the market to repair the dreaded abdominal aortic aneurysm (AAA), but these carry some serious risks that have prompted multiple FDA advisories. The agency’s latest announcement recommends routine clinical follow-up for these patients for life, and the formation of a “real-world surveillance system” that may require the financial and technical assistance of industry and medical societies to develop.
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Chinese companies embrace stricter patent regulations

Feb. 28, 2022
By Zhang Mengying
Even as China sees strong and continuous growth in patent applications from its medical technology industry, regulators are imposing stricter regulations to curb what they see as "abnormal applications." China’s medical technology sector saw year-on-year growth of 28.7% in 2021 for valid invention patents, according to data from the China National Intellectual Property Administration.
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Stepped arrow

US FDA says first-cycle PMA major deficiency rates spiked in CY 2021

Feb. 28, 2022
By Mark McCarty
The U.S. FDA’s device center has posted a report on premarket review performance metrics under the current device user fee schedule, and the latest data show an 83% rate of deficiency in first-cycle reviews of PMA original filings in the last three months of calendar year 2021. That rate is down somewhat from the 91% rate seen in 2016, but is up substantially from the 63% major deficiency rate seen in 2018, the low-water mark for this metric for more than a decade.
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Europe gives green light to Seekin pan-cancer early detection test

Feb. 28, 2022
By Catherine Longworth
Chinese company Seekin Inc. is preparing to launch its cancer detection technology in Europe after securing CE marking for the Seekincare pan-cancer test. The artificial intelligence, blood-based platform uses insights from public and private data to identify cancer DNA and protein signals in the blood. The test has been available in Chinese labs since 2018.
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HHS: More work to do as global drug, device supply chains recover

Feb. 28, 2022
By Mari Serebrov
The U.S. is making strides in addressing the drug and device supply chain vulnerabilities revealed by the COVID-19 pandemic, but there’s still a lot of work to do to reduce dependance on sole source suppliers and foreign manufacturing, according to a new Health and Human Services (HHS) report.
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U.S. FDA headquarters

US FDA issues CRLs to Reata, Amryt and GC Pharma

Feb. 28, 2022
By Lee Landenberger

Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28. The stock (NASDAQ:RETA) rose 25.3% as the company decides how it wants to handle the CRL.


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Regulatory actions for Feb. 28, 2022

Feb. 28, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Masimo.


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Regulatory actions for Feb. 28, 2022

Feb. 28, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alvotech, Amryt, Amylyx, Astellas, Biohaven, BMS, Boehringer Ingelheim, Canbridge, Cara, Cormedix, Eisai, Eli Lilly, GC, Glaxosmithkline, Hansa, Idorsia, Immunocore, Inflarx, Merck, Moderna, Pfizer, Seagen, Sobi, Valneva, Vifor.
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Product recall concept image

FDA announces class I recall for Arrow-Trerotola thrombolytic device

Feb. 25, 2022
By Mark McCarty
The FDA reported that the recall of the Arrow-Trerotola percutaneous thrombolytic device is a class I recall due to the risk of tip damage during use. This hazard could result in detachment of the tip from the device basket, which could damage or block vessels, a potentially lethal hazard for the patient.
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