2017 FDA Compliance Regulations 
Drug & Device Law
MARCH 19, 2024
TBI was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state law, a “warning”-based cause of action against a manufacturer of an FDA-regulated prescription drug or medical device for allegedly failing to report adverse events to the FDA.
Drug & Device Law
JULY 26, 2023
Hrymoc has a lot of “one-off” flavor about it, as it was tried under North Carolina law in late 2017. So plaintiffs will not be able to hide the truth of FDA regulation from the jury on retrial, while misleading the jury, nor try the same trick in any other pelvic mesh case in New Jersey going forward. labeling regulations.
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