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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But average watch-time and views of the recording after the fact suggest the educational goals of the meeting may have been met.
Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.
One of US FDA’s most important publications ever, the Orange Book celebrates 40 years as the definitive guide to approved drug products and therapeutic equivalents. Even as the color has receded from the book itself, orange still generates appreciation from regulators and outside attorneys.