FDA re­jects Intar­cia’s hot­ly pro­mot­ed di­a­betes drug/de­vice, cit­ing man­u­fac­tur­ing is­sues

Boston-based Intar­cia Ther­a­peu­tics be­came the lat­est ca­su­al­ty of the FDA’s man­u­fac­tur­ing stan­dards. The agency has re­ject­ed Intar­cia’s im­plant­ed di­a­betes drug/de­vice, which com­pa­ny ex­ecs have long in­sist­ed is on a straight path to block­buster sales.

Right now, says the biotech, it’s on a clear path to fix­ing the prob­lems — what­ev­er reg­u­la­tors found. The biotech says it does not ex­pect to be or­dered to con­duct “new piv­otal tri­als or any long lead-time CMC ac­tiv­i­ties.” That sounds sim­ple, but in this sys­tem, CRL let­ters are pri­vate, with no way to check for ac­cu­ra­cy or parse the word “piv­otal.”

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