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
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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
New FDA Draft Guidance Addresses Companion Diagnostics
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) released another draft guidance document last week that addresses…
New FDA Guidances Address NGS and Supporting Variant Databases
From - National Intelligence Report
Promoting flexibility and efficiency, the U.S. Food and Drug Administration (FDA) issued two draft guidances last week addressing oversight of…
precisionFDA Challenges Support Innovation
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FDA Approves First Liquid Biopsy Companion Diagnostic for Lung Cancer
From - National Intelligence Report
Roche announced last week that the U.S. Food and Drug Administration (FDA) approved the cobas® EGFR Mutation Test v2 "for use with…
House Appropriations Bill Seeks to Halt FDA Regulation of LDTs
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