ACLA released, on the web here, its oral comments at the January 8-9,2015 FDA public workshop on LDT regulation.
Last summer, the FDA responded to three Citizen's Petitions for and against FDA LDT regulation, with the petitions and the FDA's responses to each clipped below.
'06, '08, '13 Petition
7/2014 FDA Response
The subscription website Genomeweb interviews the ACLA legal authors, here, and a counterpoint, here.
- Also this week, the AMA publicly released its letter to the House "21st Century Cures" group, which requested public feedback on the FDA LDT issue by this week.
- AMA document, here.