US FDA May Ask Congress For More Resources After Withdrawing Generic Label Reg
Label updates for older generics are still planned, Commissioner Gottlieb says, but will depend more on sponsor collaboration as well as additional resources and authorities from Congress.
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Generics Firms Deterred From Continuous Manufacturing
Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.