The FDA today released the full version of its draft guidance on LDT regulation, and also its draft guidance covering notification and reporting by LDT developers (the previously released copy of the regulatory guidance was titled “Anticipated Details,”...
The video coverage of the September 9 House Energy and Commerce Health Subcommittee hearing regarding the FDA’s intention to issue draft guidance on laboratory-developed tests has been posted online t house.gov. Among key discussion points was FDA’s...
Originally posted September 10, 2014, by Kelly Kearsley on startupbend.com 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...
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...
The American Association for Cancer Research has published a policy statement urging the FDA to regulate high risk LDTs. The fact that FDA intends to do so certainly isn’t news to anyone who is following the issue, but this is the first such statement that I...
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