FDA is­sues new guid­ance for changes to dis­pos­able man­u­fac­tur­ing ma­te­ri­als

While the FDA is step­ping up in­spec­tions of man­u­fac­tur­ing sites af­ter Covid-19 caused de­lays, the reg­u­la­tor has is­sued new guid­ance to the in­dus­try sur­round­ing changes re­gard­ing dis­pos­able ma­te­ri­als.

The guid­ance states that any changes to dis­pos­able ma­te­ri­als used pri­mar­i­ly in drug and bi­o­log­i­cal prod­uct man­u­fac­tur­ing, in­clud­ing at con­tract man­u­fac­tur­ing sites, must “be avail­able up­on re­quest dur­ing an FDA in­spec­tion.”

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