FDA Cites Long-Term Precedent In Blocking Retail Genetic Screening Plans
This article was originally published in The Pink Sheet Daily
Executive Summary
A particularly public pre-emptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans this week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move signals no changes to its enforcement policy for laboratory-developed tests.