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.
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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.
Concept would allow more time for sponsors to make launch plans and could help improve communication under GDUFA.
FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.