FDA Drug Shortage Advice: Talk To Us Early; We’ll Be Discreet
This article was originally published in The Pink Sheet Daily
Manufacturers shouldn’t be afraid to work with FDA on preventing drug shortages for fear of public shaming, agency says.
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But agency's policy changes have failed to ameliorate ongoing shortages, GAO finds.
GAO says ongoing drug shortages are increasing, but FDA says they are flattening; contrasting definitions of “shortage” produce the disparate results.
Despite a growing number of shortages, FDA has helped to prevent many more through its early notification program. An agency official predicted that shortages will be fewer this year thanks to combined FDA and industry efforts and intervention strategies.