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Premier’s device has been cleared to test for amphetamine, methamphetamine, marijuana, cocaine, opiates, and phencyclidine, in addition to the two new assays. Read More
FDA Commissioner Scott Gottlieb said the third-party reviews “must be equivalent in rigor and completeness to the kinds of reviews that we’d conduct.” Read More
AdvaMed asked the FDA to give more examples of combination product types and manufacturing processes for which good manufacturing practices diverge from standard combination product CGMPs. Read More