Approval Of Astellas’ Myrbetriq Shows FDA’s Faith In Post-Marketing Studies
This article was originally published in The Pink Sheet Daily
Myrbetriq is approved for overactive bladder, but FDA requires trials looking at CV outcomes and malignant events, and lowers the starting dose from the sponsor’s proposal.
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Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents
Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.
Investigators should plan to find the vital status of discontinued patients, guidances states. Participants need frequent reminders to complete PRO instruments, agency recommends.