Regulatory

The decision to revoke FDA oversight of LDTs is no longer clear after HHS removed its initial statement

Industry concerns about IVDR implementation timelines

Frequently asked questions about IVDR

The benefits of ending a trial early must be weighed carefully against the risks

Diagnostic laboratories must improve their level of safety to protect laboratorians from infections

Laboratories often struggle with quality assessments because they don't fully understand the impact these reviews can have on patient care

Pathologists must consider licensing requirements, data privacy, consent, and quality control

The Laboratory Access for Beneficiaries Act will delay PAMA data reporting by one year

How to apply OSHA guidelines in a clinical setting

Precautions must be taken to minimize staff exposure to biological agents

CMS has reopened it's decision on next-generation sequencing in patients with advanced cancers

Hospital outreach labs are now challenged to collect and report private payer pricing, but there may be an upside

The immediate and lingering effects on agencies and people

Proposal of a single regulatory pathway for kits and LDTs spurs controversy

How an automated workstation can create an audit-ready clinical lab

Better communication about privacy and confidentiality can help encourage potential biobank donors

Regulatory requirements aim to get the right results to the right patients