Reporting Noncompliance in Clinical Labs Requires the Right Channels and Culture
A lawyer advises medical laboratories on how to improve their avenues for reporting unethical behavior
National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
No Signs of the DOJ Letting Off the Pedal with Medicare Fraud Investigations
However, a new memo instructs federal prosecutors to ‘avoid overreach’ when parties cooperate with authorities
Massachusetts Targets Self-Referral of Laboratory Services
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Debate Continues Over FDA Regulation of LDTs
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New Webinar
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Colon Cancer Screening Test Gets FDA Approval, Proposed Medicare Coverage
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
Labs Finalizing Policies and Procedures Under Patient Access Rule
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FDA Official Defends Plan to Issue Guidance for LDTs
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