The controversy over the U.S. FDA’s authority to regulate lab-developed tests (LDTs) took on a new set of considerations due to the COVID-19 pandemic. However, a June 22 memo by HHS General Counsel Robert Charrow pokes holes in the FDA’s argument on several fronts. Among these is the question of whether an LDT can be regulated by the FDA, given that a test is not usually offered for sale across state lines.

Talk turned skeptical well before lunchtime in the meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to consider Biogen Inc.’s aducanumab for Alzheimer’s disease, and it stayed that way until the end, when panelists voted thumbs down.

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.

Taiwan’s FDA rolled out two new supplementary regulations on periodic safety updates and adverse event notifications for medical devices in October. They are part of its Medical Device Management Law that was reported on Jan. 15. As Taiwan is stepping up innovation of and regulation for medical devices, the nation for the first time decided to separate the regulation of medical devices from pharmaceutical products.