Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs at the […]
March 6, 2023, Intelligence: Late-Breaking Lab News
- By Scott Wallask
- > From the Volume XXX No. 4 - March 6, 2023 Issue
- Tags: American Clinical Laboratory Association, BioReference Laboratories, Center for Devices and Radiological Health, Department of Health and Human Services Office of Civil Rights, digital pathology association, Elizabeth Hillebrenner, FDA, Food and Drug Administration, HIPAA, Karan Saldana, laboratory-developed test, ldt, Life Hope Labs, Liron Pantanowitz, Quest Diagnostics, U.S. HealthTek, University of Michigan, University of Pittsburgh School of Medicine, VALID Act, Verifying Accurate Leading-edge IVCT Development Act
