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20 Aug 2013, 1:14 pm by Michelle Yeary
Nidek Corp., 711 F.3d 1109 (9th Cir. 2013). [read post]
4 Jun 2015, 5:56 am
., 2015 WL 2457643, at *9 (“California directly incorporates the federal new-drug application regulations”).Thus, as we explained in much greater detail in our earlier Athena post, the result was an injunction against selling an unapproved “drug,” even though the FDA had never determined that this product was a “drug” that required pre-marketing approval in the first place. [read post]