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Home » Topics » Regulatory

Regulatory
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Almonertinib receives approval in China for EGFR T790M-mutant NSCLC

March 20, 2020

Regulatory front for March 19, 2020

March 19, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CME America, Mesa Biotech.
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Coronavirus and DNA

FDA greenlights emergency use of Abbott SARS-CoV-2 test

March 19, 2020
By Meg Bryant
Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month.
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Thumbs down

FDA rejects de novo application for Aussie digital health company Resapp’s respiratory diagnostic

March 19, 2020
By Tamra Sami
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
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Regulatory front for March 19, 2020

March 19, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Intercept.
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FDA, drug developers grapple with COVID-19's impact on trials

March 18, 2020
By Michael Fitzhugh
With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic.
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Regulatory front for March 18, 2020

March 18, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Australian flag marking country on globe

TGA refines proposals to reclassify six groups of medical devices based on industry comments

March 18, 2020
By Tamra Sami
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Aug. 25, 2020, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
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China approves first homegrown COVID-19 vaccine to enter clinical trials

March 18, 2020
By Elise Mak
BEIJING – One day after the U.S. began the first human trial of an mRNA vaccine candidate for COVID-19 on March 16, China said Tuesday evening that it had approved the first clinical trial of a vaccine candidate developed by domestic researchers.
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Regulatory front for March 18, 2020

March 18, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Astrazeneca, Boehringer Ingelheim, Janssen, Lilly, Merck.
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