Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
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
Next-Gen Sequencing Has Significant Utility for Drug-Resistant Epilepsy
From - Diagnostic Testing & Emerging Technologies
Next-generation sequencing improves definitive diagnoses for children with drug-resistant epilepsy, according to a pilot study published online…
Compliance Perspectives: Genetic Test Labs Face Growing Risk of Medical Malpractice Liability
From - G2 Compliance Advisor
Compliance managers of lab involved in the $3 billion consumer-based genetic testing business need to safeguard their flank against a growing legal risk…
FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
From - National Intelligence Report
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four…
Where’s your lab safety manual?
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Laboratory leadership should be committed to providing a safe working environment, and they should believe their employees have a right to know…