Biodel’s Linjeta likely to face delayed PDUFA in fallout from CMO manufacturing violations – industry sources

This article describes the implications of a recent FDA warning letter regarding serious manufacturing issues related to Linjeta, an injectable insulin product. Catalyst President Nancy Bradish Myers comments on the variables that will dictate whether the product’s PDUFA date will be delayed.

“Biodel’s Linjeta likely to face delayed PDUFA in fallout from CMO manufacturing violations – industry sources”

Pharmawire

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2017-11-19T18:57:02+00:00