FDA/Generic Communications Plan Restoring Best Of Past Practices
This article was originally published in The Pink Sheet Daily
Executive Summary
Office of Generic Drugs wants to allow project managers to inform sponsors of major deficiencies before ‘complete response’ letter as part of ‘go/no go’ effort.
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Generic Drug Sponsors Seek Advance Notice Of Approvals From US FDA
Pre-launch communication from agency would allow sponsors to ramp up commercial activities and could head off some innovator company legal challenges to ANDA approvals, attorneys say; CDER’s Moscicki suggests GDUFA goal dates now provide sponsors some level of predictability.