HCFA Meta-Analysis For PET Technology Review Published In JAMA
This article was originally published in The Gray Sheet
Executive SummaryA meta-analysis of FDG-PET studies published the Feb. 21 Journal of the American Medical Association finds no evidence to conclude that modified gamma cameras are less accurate than dedicated PET scanners in diagnosing lung cancer.
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Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.