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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3D Systems, Avinger, Eurofins Scientific, Oxford Immunotec, Pear Therapeutics, Sectra, Veracyte.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of discontinued Medtronic catheter.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Biolytical Laboratories, DNA Genotek, Pari Pharma, Salvia Bioelectronics.
October brought another burgeoning swell of pandemic news with the U.S. granting its first FDA approval for a COVID-19 therapy, a promising vaccine candidate reaching full enrollment in phase III, and the stoppage of several trials due to safety signals.
LONDON – People infected with COVID-19 are likely to have T-cell immunity six months after contracting the virus, according to a U.K. study of 100 subjects who had an asymptomatic or mild to moderate infection.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS announces testing agreements; TGA slaps two companies for violations.
The U.S. FDA is no longer reviewing lab-developed tests (LDTs) under the emergency use authorization (EUA) program, which eliminates product liability protection for them under the Public Readiness and Emergency Preparedness (PREP) Act. Harvard’s Michael Mina said on an Oct. 30 press briefing that the PREP Act question could be extended to LDTs administratively even outside EUA review, a move he said is under consideration based on his communications with Assistant Secretary for Health Brett Giroir.
