Warning Letter Roundup & Recap – 16 September 2020
Two companies were sent FDA warning letters for selling adulterated COVID-19 tests, while a third was dinged for selling its transilluminator device for breast evaluation without agency approval or clearance.
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Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.
CDRH director Jeff Shuren says the US agency’s device center has been tallying up lessons learned from the COVID-19 pandemic.
The US HHS played defense on 20 September, pushing back on suggestions that secretary Alex Azar’s recent move to exert control over regulations by signing off on them was a power play aimed at the FDA. Meanwhile, former agency head Scott Gottlieb says it’s “the wrong move at the wrong time.”