Survey Shows Improved FDA Relationship With Industry Since FDAMA
This article was originally published in The Gray Sheet
Executive SummaryFDA Center for Devices and Radiological Health's use of National Institute of Dental Research expertise in the area of dental products is one example of ways that the device center is responding to the increasing complexity of device submissions and shrinking budgetary resources.
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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.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.