Collegium Targets Remoxy ER Through Citizen Petition Process – Again
Executive Summary
Citizen petition resembles July 2016 petition targeting extended-release oxycodone products, but this time names the products it's worries about.
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FDA's complete response letter includes extensive list of new studies needed to support abuse-deterrence claims not featured in two prior CRLs, Pain Therapeutics says, wondering why the agency is only now raising issues that could have been discussed previously.