1. Pink Sheet

Generic Drug Sponsors Seek Advance Notice Of Approvals From US FDA

 
• By Sue Sutter

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.

Launch Plans words stamped in red ink on yellow envelope offering advice, information

Generic drug sponsors are seeking the US FDA’s assistance to help them better prepare for product launch immediately upon abbreviated new drug application (ANDA) approval.

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