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Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
FDA Issues Report Citing Case Studies It Argues Supports Need for More Oversight of LDTs
By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Food and Drug Administration (FDA) released a 30-plus page report yesterday detailing case studies it says demonstrate the need for the FDA to abandon its policy of enforcement discretion and...
DNA4Life Is Latest DTC Genetic Test Company to Receive FDA Letter
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Direct-to-consumer startup DNA4Life (Mandeville, La.) is the latest recipient of a letter from the U.S. Food and Drug Administration (FDA) questioning the company's marketing of an unapproved...
Harmonyx Tests to Be Distributed Through Rite Aid
By Ron Shinkman, Editor, Laboratory Industry Report Harmonyx, the Tennessee-based molecular laboratory, has struck a deal with pharmacy chain Rite Aid to sell its pharmacogenetic assays at its retail stores. Customers will be able to purchase the Harmonyx test at...
HCCA Offers Compliance Officer and Staff Compensation Survey
By Kelly A. Briganti, Editorial Director, G2 Intelligence Just in time for budget season, the Health Care Compliance Association has released a report demonstrating the resources health care organizations are devoting to their compliance programs. The report...
OIG Releases 2016 Work Plan; Report on Lab Payments Expected
By Kelly A. Briganti, Editorial Director, G2 Intelligence Last week the OIG released its 2016 Work Plan that continues to name laboratories as a source of concern with regard to Medicare billing and payment. The OIG's annual Work Plan provides a summary of new and...