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Insulin vials and syringe

Deeming day dawns Monday for insulin, other small proteins

March 20, 2020
By Mari Serebrov
As if the FDA doesn’t have enough on its hands with COVID-19, Monday is deeming day. That’s the day nearly 100 drugs approved via new drug applications (NDAs) are to be deemed biologics, courtesy of the 2010 Biologic Price Competition and Innovation Act (BPCIA).
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Regulatory front for March 20, 2020

March 20, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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FDA approves Epclusa for pediatric patients with hepatitis C

March 20, 2020

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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