LDTs
Sequenom Disputes FDA Letter on Genetic Test
Aug 25, 2010
Companies have had varying responses to FDA's recent investigation of genetic tests. MD+DI columnnist Jim Dickinson adds:   San Diego-based Sequenom says...
FDA Backs Risk-Based Approach for Lab Tests
Aug 05, 2010
CDRH says moving forward with a risk-based approach for providing regulatory oversight over laboratory-developed and commercially marketed tests will help...
LDTs Still Face Pressure from FDA
Oct 08, 2009
There is no timeline yet for doing it, but FDA still intends to regulate laboratory-developed tests (LDTs) under FDA “enforcement discretion,” CDRH acting...