Rare disease outfit Acer fumbles at FDA, receiving CRL due to lack of inspection readiness at packaging manufacturer

It’s never fun to receive a CRL, but perhaps even less so when the rejection has to do with manufacturing rather than the drug. …

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Rare dis­ease out­fit Ac­er fum­bles at FDA, re­ceiv­ing CRL due to lack of in­spec­tion readi­ness at pack­ag­ing man­u­fac­tur­er