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Regulatory front for March 4, 2020

March 4, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Clinical Laboratory Association, DNA Technologies, Texas Instruments, Dialog Semiconductors, Telink Semiconductors.
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Doctor pointing at liver

Roche scores breakthrough device designation for Elecsys GALAD score

March 4, 2020
By Liz Hollis
With an eye toward helping those with early stage hepatocellular carcinoma (HCC), Basel, Switzerland-based Roche Group has won a breakthrough device designation from the U.S. FDA for the Elecsys GALAD score. When combined with ultrasound, the Elecsys GALAD score aims to help provide more accurate information for clinicians to treat patients at an earlier stage.
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Japanese flag

Japan’s medical device price cut set to be smaller in 2020

March 4, 2020
By Jihyun Kim
HONG KONG – Japan cuts medical device prices every two years to manage increasing health care costs. This year, the biennial medical device price cut will take effect beginning on April 1, 2020.
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Map, flag of India

India restricts export of certain APIs; expert says ‘It’s not a ban’

March 4, 2020
By David Ho and Elise Mak
HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs. In a note dated March 3, India’s Directorate General of Foreign Trade compiled a list of now restricted APIs and formulations that were previously free to export. It ranged from paracetamol and erythromycin salts to progesterone and vitamin B1, 6 and 12.
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Regulatory front for March 4, 2020

March 4, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: Merck & Co., Outlook Pharmaceuticals.


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Architectural pillars

Regulatory front for March 3, 2020

March 3, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: FDA, Yibin Lihao Bio-technical.


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Brexit scissors illustration

With Brexit split, Australia ready with back-up plan for drugs and devices following transition

March 3, 2020
By Tamra Sami
PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends.
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Singapore’s Tessa gains U.S. RMAT designation for CD30 CAR T, expands manufacturing efforts

March 3, 2020
By David Ho
HONG KONG – Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy designation by the U.S. FDA based on data from two independent phase I/II trials.
Read More

Regulatory front for March 3, 2020

March 3, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More
3-3-Xatek-clotchip.png

Xatek wins breakthrough status for portable clotting sensor

March 3, 2020
By Meg Bryant
With trauma patients and those suffering from bleeding disorders, being able to quickly assess a person’s bleeding risk can be lifesaving, but most current tests to measure clotting ability are laboratory-based and don’t provide immediate results. To that end, the U.S. FDA has granted Cleveland-based Xatek Inc. breakthrough device designation for its Clotchip portable blood clotting sensor.
Read More
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