Technology adoption in managed care
This article was originally published in The Gray Sheet
Executive SummaryHealth Industry Manufacturers Association wins a contract from the state of California to conduct a study on best practices for introducing emerging medical technologies into the managed care setting. The 12-month survey, which will poll both device and managed care firms, will identify obstacles to making needed products available to patients, HIMA says
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.