FDA is narrowing the focus of its proposed guidelines for manufacturers of gene-based tests from its original 2003 draft in response to comments from industry members and scientists, according to a revised 1draft guidance document issued Feb. 9
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Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.
