FDA Drug Shortage Advice: Talk To Us Early; We’ll Be Discreet

Manufacturers shouldn’t be afraid to work with FDA on preventing drug shortages for fear of public shaming, agency says.

Working with FDA to prevent a drug shortage situation doesn’t automatically put a company’s manufacturing issues in the public spotlight and instead could actually prevent bad press if the shortage never occurs, Associate Director in CDER’s Drug Shortage Program Valerie Jensen, said.

FDA is trying to combat a false worry on behalf of companies that as soon as they let FDA know...

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