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Latest From Elizabeth Orr
FDA Urges Caution in Some Neurovascular Stent Use
US FDA has issued new guidelines to providers because some patients experienced strokes or died after being treated for unruptured brain aneurysms with some neurovascular stents.
US FDA Finds Ongoing CAPA Issues In Zimmer Plant Reinspection
A follow-up inspection evaluating Zimmer Biomet’s progress in remediating issues documented in a 2016 FDA Form-483 uncovered 11 observations, eight of them repeats.
Watchdog OKs Ostomy Company Samples
An ostomy supply manufacturer can give free samples to potential clients without violating anti-kickback rules, the US Department of Health & Human Services’ Office of the Inspector General wrote in a recent advisory opinion.
DOJ Memo Could Offer Additional Defenses In Enforcement Actions
Industry should be cautious in interpreting a recent US Department of Justice memo stating DOJ wouldn’t take enforcement actions based on failure to comply with guidance documents alone, according to experts. But the document still could offer assistance to manufacturers fighting enforcement actions.
FDA Chief Counsel Addresses First Amendment, Enforcement
US FDA Chief Counsel Rebecca Wood discussed ongoing reforms to FDA’s free speech enforcement approach and other enforcement priorities at a recent conference.
Warning Letter Close-Outs – April 2018
US FDA released one device-related close-out letter in March.