CDER director urges manufacturers to work with FDA to fix inspection issues before shutting down

As pol­i­cy­mak­ers con­tin­ue to chip away at fix­es to on­go­ing drug short­ages, the FDA’s drug cen­ter head is urg­ing man­u­fac­tur­ers to work with FDA on in­spec­tion is­sues be­fore halt­ing pro­duc­tion of crit­i­cal med­ica­tions.

Dur­ing a pre­sen­ta­tion at the FDA’s joint meet­ing with the Par­enter­al Drug As­so­ci­a­tion on Mon­day, FDA’s CDER Di­rec­tor Pa­trizia Cavaz­zoni ex­plained that there is lit­tle mar­ket in­cen­tive for man­u­fac­tur­ers to pro­duce ex­cess prod­uct, which is par­tic­u­lar­ly an is­sue for ster­ile in­jecta­bles like com­mon can­cer drugs. As of Aug. 16, can­cer med­ica­tions were in on­go­ing short­age, she said.

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