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Home » Topics » Regulatory

Regulatory
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Health Canada grants first global regulatory approval for Cabenuva

March 23, 2020

Regulatory front for March 20, 2020

March 20, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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3-20-France-Agnes-Buzyn.png

France is upping the financial pressure on medical devices

March 20, 2020
By Bernard Banga
PARIS – The French government is seeking to curb the growth in spending on medical devices. According to recent work by the parliamentary information commission, led by deputies Julien Borowczyk and Pierre Dharréville, medical technology is the source of $5.8 billion in annual spending in the community and $2.1 billion in hospitals.
Read More
Lungs

FDA says yes to NO: Bellerophon Therapeutics wins expanded access approval for inhaled nitric oxide system

March 20, 2020
By Cormac Sheridan
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data presented by Bellerophon Therapeutics Inc. to grant it expanded access approval for its iNOpulse system for pulmonary delivery of NO.
Read More
Flag of China and masks

Policy advocates propose measures for clinical disruptions in China

March 20, 2020
By Elise Mak and Cornelia Zou
BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks and address the concerns of a biotech industry in dismay.
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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).
Read More

Regulatory front for March 20, 2020

March 20, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More

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.
Read More
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