FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
FDA-nir
Subscribe today for access to
Articles and Reports
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
Two FDA Workshops Focus on Precision Medicine Issues
...
Already a member? Log in here
AMP Offers Proposal for Regulation of Laboratory-Developed Tests
...
Already a member? Log in here
CMS Releases New CLIA-Waived Tests, Billing Codes
...
Already a member? Log in here
Researchers Call for Regulatory Oversight of Genomic Tests
...
Already a member? Log in here
CMS Withdraws Memorandum, Seeks Public Comment on Blood Glucose Monitoring
...
Already a member? Log in here
FDA Seeks Stakeholder Feedback on Evaluating Next-Generation Sequencing Tests
...
Already a member? Log in here
FDA Issues Guidance Affecting Digital Pathology Whole Slide Imaging
...
Already a member? Log in here
CMS Releases New CLIA-Waived Tests, Billing Codes
...
Already a member? Log in here