In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA ...
Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in ...
Two Japanese drugmakers and another in India were hit with Form 483s from the FDA following inspections that uncovered issues ...
The US Food and Drug Administration on Friday approved the first flu vaccine that does not have to be administered by a ...
WASHINGTON — It's been three years since Spotlight on America started investigating reports of breakage and complications ...
And in January, the FDA approved Florida’s state importation plan ... in reality, who is doing the inspections? Is there a ...
Even trace amounts of impurities in medication can spell trouble. Yet, recent research shows that nearly one-third of ...
iRhythm’s stock price has been volatile over the past five years, climbing as high as $274.21 and declining as low as $41.66. It was down 30 percent for 2024 and stood at $86.25 the day before the ...
Spotlight on America has obtained documents revealing safety concerns raised after FDA inspections of the Paragard manufacturing facility in Buffalo, New York. It never disclosed that it had ...