Titan’s Probuphine May Be Limited By Implant Procedure
Extensive requirements for training and equipping non-surgical specialists to implant the product for opioid dependence treatment may scare some clinicians away from using it, advisory committee members say.
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Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.
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.