US breaks away from tripartite agreement on biocompatibility
This article was originally published in Clinica
The US FDA is to introduce new guidance on biocompatibility standards for medical devices from July 1st, according to a May 1st memorandum from the Department of Health and Human Services. The guidance is based on Part-1 of the ISO standard, Biological Evaluation of Medical Devices, and replaces the Tripartite Biocompatibility Guidance, G87-1, issued in 1986 by the US, Canada and the UK and used by reviewers and manufacturers alike.
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.