Policy & Legislation
News on government policy and legislation impacting life science and diagnostics.
The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.
Cystic Fibrosis Newborn Screening to Include All Genetic Variants, Foundation Suggests
The US Cystic Fibrosis Foundation (CFF) released new guidelines for screening newborns for cystic fibrosis (CF)-causing gene variants.
The lab, one of three branches of the NCHHSTP's Division of Viral Hepatitis, was eliminated while working on several ongoing hepatitis outbreaks.
The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.
Federal Court Vacates FDA Rule on Laboratory-Developed Tests
The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical lab industry and many segments of the broader healthcare industry, from going into effect.