FiercePharma2d
In addressing inspection shortfall, FDA says it's gaining more inspectors than it's losing
In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA ...
Nearly 2,000 drug manufacturing plants are overdue for FDA inspections after COVID delays, AP finds
Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in ...
FDA’s inspections still lag pre-pandemic period
Under the FDA's own guidelines, factories that haven't been inspected in five or more years are considered a significant risk ...
FDA quietly launches safety review into IUD breakage amid our Paragard investigation
WASHINGTON — It's been three years since Spotlight on America started investigating reports of breakage and complications ...
The Miami Times11d
FDA has massive backlog of factory inspections
Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in ...
JD Supra5d
FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests
The U.S. Food and Drug Administration's (FDA) warning letter to Agena Bioscience, issued on March 21, 2024, marks a significant shift in enforcement priorities, targeting the improper labeling of ...
FiercePharma12d
FDA issues Form 483s to Japanese, Indian drugmakers in wake of plant inspections
Two Japanese drugmakers and another in India were hit with Form 483s from the FDA following inspections that uncovered issues ...
WTHI-TV2d
FDA approves first flu vaccine that can be self-administered at home
The US Food and Drug Administration on Friday approved the first flu vaccine that does not have to be administered by a ...
Staten Island Advance17h
New Yorkers could be popping cheaper Canadian prescription drugs if proposed bill succeeds
And in January, the FDA approved Florida’s state importation plan ... in reality, who is doing the inspections? Is there a ...