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The agency “has not specifically evaluated implementation of the least burdensome requirements,” according to the Government Accountability Office. Read More
“We do not want to imply that all other decisions of the agency that do not fall within section 517A of the FD&C Act are not significant,” a new proposed rule states. Read More
Congress’s failure to pass a government funding bill last weekend means much — but not all — of FDA’s work will stop until an appropriations bill is passed. Read More
“We aim to have more than 50 percent of manufacturers of novel technologies…intend to bring their devices to the U.S. first or in parallel with other major markets by December 31, 2020,” said CDRH Director Jeff Shuren. Read More
DoD’s Office of Health Affairs and the FDA will collaborate in reviewing products meant to treat, prevent or diagnose serious or life-threatening conditions for troops. Read More
The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant CGMP violations. Read More