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Posts From the monthly archives: "September 2014"

The FDA today released the full version of its draft guidance on LDT regulation, and also its draft guidance covering notification and reporting by LDT developers (the previously released copy of the regulatory guidance was titled “Anticipated Details,” and was pre-released in response to Congressional pressure). The regulatory guidance seems essentially unchanged from the…(Read More)

Originally posted September 10, 2014, by Kelly Kearsley on The #50startups project kicks off now with Amplion Research. (Heads up: We’re about to get all science-y. It’s good for you). The Bend-based software startup aggregates biomarker data and then makes it easier for drug, diagnostic and life sciences companies…(Read More)

Following quickly on the heels of the AACR statement in support of FDA regulation of LDTs, the co-founder of The Coalition for 21st Century Medicine, Kathleen Wilsey, today presented to Congress testimony that includes significant concerns about the potential for negative impacts from FDA regulation. The Coalition’s general concerns are that FDA’s…(Read More)