Federal rulemaking freeze would end Dec. 31 at latest under House committee mark-up.
This article was originally published in The Gray Sheet
Executive SummaryFEDERAL RULEMAKING FREEZE WOULD END DEC. 31 AT THE LATEST under an amendment to HR 450 adopted by the House Government Reform and Oversight Committee during mark-up on Feb. 13. The amendment to the "Regulatory Transition Act of 1995" states that the regulatory moratorium would end either on Dec. 31, 1995 or when regulatory reform legislation is enacted, whichever occurs first.
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.