Thanks to the pandemic caused by the SARS-CoV-2 coronavirus identified in late December 2019, 2020 was the year of COVID-19. It was a year of lockdowns and social distancing, a year of Zoom meetings and virtual conferences, and a year when donning a face mask sometimes came to signify a political rather than health decision.
It has been a year since Wuhan health authorities first issued a bulletin about a cluster of pneumonia cases of unknown cause, first bringing what would become the COVID-19 pandemic to the attention of the World Health Organization. Now, a mutation that significantly increases SARS-CoV-2’s transmissibility has been detected in the U.S.
LONDON – Controversy has erupted over COVID-19 vaccines dosing after the U.K. said it is to prioritize giving as many people as possible a single dose of the two currently approved products, rather than two doses three or four weeks apart, as scheduled on their labels. The move prompted a sharp rebuke from FDA Commissioner Stephen Hahn and Peter Marks, director of FDA’s Center for Biologics Evaluation, who said any such change “is not rooted in the science.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO says wound care spending dropped between 2016 and 2018; FDA updates COVID testing data; May 2019 Q-sub guidance appears in final form.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Bioserenity, Nirmidas Biotech, Spark Biomedical, Trinity Biotech.
Relief spread across the world in December when the first two mRNA COVID-19 vaccines received emergency use approvals, although that deep sigh was short-lived as a highly-transmissible SARS-COV-2 mutation began to make its rounds, highlighting the need for continued research to strengthen the arsenal.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Curative test for COVID should be conducted per product label; FDA posts MEA final guidance; CMS eyes radiology quality measures; Ra Medical agrees to fines.
Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.
As is the case with many national governments, the U.S. federal government does not routinely measure its activities in the calendar year, but we at BioWorld don’t share that outlook. CY 2020 was odd in more ways than one from a regulatory standpoint, and thus we offer our version of a regulatory top 10 for a year that might not look much better in the rear-view mirror than it has looked as a current event.
