EU notified body awaits Californian court decision
This article was originally published in Clinica
TUV Product Services, of Germany, has become the first notified body to be named in a US product liability suit. The certification body has confirmed that a case has been brought against it in a Californian court connected with its certification of the Trilucent breast implant. This soya bean oil filled implant has been recalled in Europe because of safety concerns.
You may also be interested in...
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.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.