Compliance Perspectives-lca

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Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule

By Rachel Muenz | Nov 21, 2024 | 1 min read

Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule

A group of four laboratory professionals, three standing and one sitting, meet in the laboratory. Two of the lab professionals are holding clipboards.

How the LDT Final Rule’s Exemptions Apply to Oncology Labs

By Scott Wallask | Nov 7, 2024 | 1 min read

Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines

A closeup image of a female laboratory assistant in PPE typing on a laptop at the laboratory bench

What Labs Need to Know About Reporting Adverse Events to the FDA

By Tara Cepull, MA | Nov 1, 2024 | 1 min read

Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events

Closeup of a laboratory professional in PPE sitting at a desk with a computer monitor and filling out a form on a clipboard.

Compliance Perspectives: Defending the Medical Necessity of Anatomic, Clinical Pathology Services

By Glenn S. Demby | Feb 23, 2015 | 1 min read

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Compliance Perspectives: It’s Time to Look Forward: Make a List and Check It Twice

By Glenn S. Demby | Feb 23, 2015 | 1 min read

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Compliance Perspectives: It’s Time to Look Forward: Make a List and Check It Twice

By Glenn S. Demby | Feb 23, 2015 | 1 min read

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This content is for Paid Members only.
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