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FDA Advisory Committees

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Sarepta Protocol Changes Could Impact Future Duchenne Trials

If US FDA Commissioner Gottlieb allows use of in-dwelling ports in ESSENCE study, Office of Pediatric Therapeutics will assess whether the determination could serve as precedent for placebo-controlled trials of other exon-skipping compounds in Duchenne muscular dystrophy.

Advisory Committees Clinical Trials

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees

Sarepta’s ESSENCE Trial Gets FDA Panel Nod For Protocol Changes

US agency’s experts unanimously support allowing use of in-dwelling ports to aid infusions in trial of two Duchenne muscular dystrophy compounds, while also endorsing the two-year, double-blind, placebo-controlled design, which was influenced by the clinical experience with Exondys 51 (eteplirsen).

Advisory Committees Pediatrics

RSV Vaccines Need Multiple Animal Models Before Infant Testing, Panel Says

US FDA's advisors want data from three animal models – not just the cotton rats that Janssen was hoping for – before candidate vaccines are tested in healthy infants.

Advisory Committees Vaccines

FDA Panel To Weigh Animal, Adult Human Data For Initiation Of RSV Vaccine Trials In Infants

Sponsors have been increasingly developing vaccine candidates for the respiratory syncytial virus with an unmet need existing for infants; the advisory committee will evaluate FDA's proposed approach for developing candidates in the target population.

Advisory Committees Vaccines

Sarepta Trial Protocol Changes May Ignite Debate On Placebo Design

US FDA’s external advisors will meet May 18 to consider allowing use of central venous access lines in a study of two Duchenne muscular dystrophy drugs. Agency briefing documents show decision-making on placebo-controlled trial design was informed by problems in the clinical development of Exondys 51 (eteplirsen).

Clinical Trials Pediatrics
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