LONDON – The Danish government has ordered a mass cull of 15 million mink following evidence the animals are harboring a variant of SARS-CoV-2 with mutations in the spike protein through which the virus infects human cells.

The COVID-19 pandemic has affected the U.S. FDA on the postmarket side as well as on the premarket side, but the focus of pandemic-driven warning letters has shifted over time. Amanda Johnston, senior attorney at Gardner Law of Stillwater, Minn., said on a Nov. 5 webinar the FDA’s emphasis lately has been closer to the agency’s traditional enforcement considerations after an initial wave of warnings dealing with flatly fraudulent products.

Becton, Dickinson and Co. (BD) reported good news Thursday, as it saw quarterly revenues of $4.784 billion for its fourth fiscal quarter, an increase of 4.4% over the prior-year period. Of note, the company’s life sciences segment saw worldwide revenues of $1.488 billion, representing an increase of 31.2% over the prior-year period as reported, or 31.4% on a currency-neutral basis.

The U.S. FDA’s stated policy is that it will not review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic, but that doesn’t mean labs are completely shut out. The FDA’s Toby Lowe said that a lab that wants to pair an assay that already has an EUA with a new software installation on lab instrumentation can work with the assay developer to update that EUA.