FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
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Articles and Reports
Roche & Quest Establish Toeholds in Emerging Alzheimer’s Blood Testing Market
While Roche has an early lead, Quest recently made key moves to improve its position in the AD patient-initiated blood testing market.
Special Report: The OSHA Inspection Process and How to Survive It
The basics of how the OSHA inspection process works and how laboratories can successfully navigate it.
12 Steps to Manage BYOD Risks to Lab Data
How lab leaders can manage the data security risks of staff using personal devices for work-related purposes.
Compliance Tool: Model Bring Your Own Device (BYOD) Policy
This BYOD policy template illustrates the basic issues lab leaders may want to address to ensure cybersecurity in their facilities.
Expected Audit Targets for 2024 and How Laboratories Can Ensure Compliance
An overview of likely lab audit targets for the coming year, and how laboratories can ensure they’re prepared.
Lab Marketing & Staffing: 4 Common Kickback Pitfalls to Avoid
How laboratories can avoid compliance issues involving certain marketing and staffing practices.
Laboratory Relocation: 6 Common Pitfalls to Avoid
Missing small details or getting them wrong can be disastrous for a lab move—here’s how to avoid major issues.
Dx Deal Roundup: A Major Proteomics Merger, Ginkgo Makes Pharma Inroads, and More Legal Woes for Illumina
As is usual at this time of year, deals in the diagnostics industry were up, both in terms of volume and value.
FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
November 2023 Labs in Court
This month’s roundup of cases includes Walgreens’ settlement with Theranos customers, kickbacks, and age discrimination.
Compliance Perspectives: When Do Cybersecurity Donations Violate Kickback Laws?
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
Compliance Tool: Model Policy on Donating Cybersecurity Technology to Physicians
This template aims to help lab leaders develop a policy for donations of cybersecurity technology that complies with safe harbor requirements.
