The U.S. Food and Drug Administration (FDA) late last week officially issued its draft framework for how the agency plans to regulate laboratory-developed tests (LDTs). The 41-page framework, which was released on Oct. 3 and is now subject to a 120-day public comment period that will extend into the middle of next February, is expected…
Lab Execs Air Concerns Over FDA Regulation of LDTs
by Glenn S. Demby | Feb 25, 2015 | CLIA-nir, FDA-nir, Focus On-nir, National Lab Reporter | 0 comments