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Home » Topics » Regulatory

Regulatory
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Going digital: EU adopts standard for EPIs

Feb. 22, 2022
By Mari Serebrov
Paving the way for wider dissemination of up-to-date information on drugs approved in the EU, the European Medicines Regulatory Network adopted a common standard for the electronic product information (EPI), which includes the package leaflet for patients and the summary of product characteristics for health care professionals.
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Regulatory actions for Feb. 22, 2022

Feb. 22, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Foundation Medicine, Gramercy Extremity Orthopedics, Lumiradx, Olympus, Precisis.
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China and U.S. flags

USTR: China falling short of WTO’s market-oriented principles

Feb. 22, 2022
By Mari Serebrov
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).
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Flag of India

India’s health care industries receive mixed messages from authorities

Feb. 22, 2022
By David Ho
India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices.
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COVID-19 vaccine and syringe with flag of China

China widens COVID-19 booster choices

Feb. 22, 2022
By Mari Serebrov
China is the latest country mixing things up when it comes to COVID-19 boosters. Since boosters were implemented in China in October, adults have been given a third dose of their primary vaccine regimen, which has consisted of one of three inactivated vaccines produced by Sinopharm Group Co. Ltd. and Sinovac Biotech Ltd.
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Regulatory actions for Feb. 22, 2022

Feb. 22, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Biomarin, Dizal, Novavax, Ose, Transthera, UCB, Veloxis.
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Toy bulldozer moving FDA letter blocks

FDA provides five more device classifications via de novo petition

Feb. 18, 2022
By Mark McCarty
The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.
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EMA icons

EMA: Increase in NCEs approved amid overall drop for 2021 and continued COVID-19 pressure

Feb. 18, 2022
By Nuala Moran
LONDON – Two years into the pandemic and the number of new drugs approved by the EMA fell from 97 approvals in 2020 to 92 in 2021. But both years are still well up on pre-COVID-19 times in 2019 when 66 products got the nod, according to the EMA’s annual human medicines report.
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Red blood cells

Agios’ pivot from oncology leads to an FDA approval in rare disease

Feb. 18, 2022
By Lee Landenberger
The FDA’s approval of Agios Therapeutics Inc.’s Pyrukynd (mitapivat) for treating hemolytic anemia marks a turnaround from nearly a year ago. That’s when Agios sold its commercial, clinical and research-stage oncology portfolio to privately held Servier Pharmaceuticals LLC to concentrate on rare diseases.
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Regulatory actions for Feb. 18, 2022

Feb. 18, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Medtronic, Ra Medical Systems.
Read More
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