FDA Opioid Progression: KemPharm's Combo To Get Cmte. Vote After Policy Review
This article was originally published in The Pink Sheet Daily
Relevance of nasal abuse will be factor for benzhydrocodone/acetaminophen product that is designed to be crush resistant.
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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.