This article was originally published in The Tan Sheet
Executive SummarySandra Kweder named deputy director of the Office of New Drugs effective June 1, FDA announces. Kweder joined the agency in 1988 as a medical officer in the Division of Antiviral Drug Products. She most recently served as acting director of the Office of Review Management from February 2001 through January 2002, and acting director of the Office of Drug Evaluation II from January 2002 through present...
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.