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.
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
How lab leaders can manage the data security risks of staff using personal devices for work-related purposes.
This BYOD policy template illustrates the basic issues lab leaders may want to address to ensure cybersecurity in their facilities.
An overview of likely lab audit targets for the coming year, and how laboratories can ensure they’re prepared.
How laboratories can avoid compliance issues involving certain marketing and staffing practices.
Missing small details or getting them wrong can be disastrous for a lab move—here’s how to avoid major issues.
As is usual at this time of year, deals in the diagnostics industry were up, both in terms of volume and value.
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
This month’s roundup of cases includes Walgreens’ settlement with Theranos customers, kickbacks, and age discrimination.
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
This template aims to help lab leaders develop a policy for donations of cybersecurity technology that complies with safe harbor requirements.