Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Pharma, AB Science, Abbvie, Armata, Bharat Biotech, Beigene, Cansino, Homology, Ocugen, Provention, RDIF.
Tariffs applied to goods imported for China were imposed by the Trump administration as part of a larger effort to reset the U.S. trade deficit, but there were several exclusions for medical devices in the interest of maintaining access.
The U.S. FDA has at last published what is nominally a draft rule for harmonization of the Quality System Regulation (QSR) with an international standard, ISO 13485, but the draft rule is conspicuous for the absence of specifics.
Abbott Laboratories’ Cardiomems heart failure (HF) system is open to a larger patient population following an expanded approval from the FDA. Abbott’s system had previously been approved for class III HF patients that had been hospitalized for HF in the past year. A new expanded indication enables the sensor to be utilized by class II (earlier stage) HF patients and those whose blood test show elevated levels of biomarkers known as natriuretic peptides. The FDA based the approval on findings from the GUIDE-HF trial, which suggested class II HF patients and patients with elevated natriuretic peptides had better outcomes when their therapy was guided by pulmonary pressure monitoring, with a 34% and 25% reduction in heart failure hospitalizations and emergency visits, respectively, based on study data adjusted for the impact of COVID-19.
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.
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.
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).
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.
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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