FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Articles and Reports
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
Building an Effective Business Case for Your Lab
An effective business case communicates need, benefit, and risks.
FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
Labs Partner with Pharma Companies to Develop New CDx Tests
There were three notable CDx alliances announced in January 2023, all of which involved cancer-related solutions.
Digital Health Fundraising Falls in 2022 but May Not Have Bottomed Out
According to a new report, tough macro-economic conditions caused digital health fundraising levels to fall off dramatically in 2022.
Does a Concierge Business Model Make Sense for Your Lab?
Factors to consider when determining if the concierge business model is best for your laboratory.
How to Regulate Workplace Romance in Your Lab
Labs and other companies need a proactive strategy for dealing with romance and fraternization between employees.
Model Conflict of Interest Policy for Employees Romantically Involved with Co-Workers
Here’s a template for a conflict of interest policy that you can adapt for your lab based on its specific situation and HR policies.
Model Workplace Romance ‘Love Contract’
Having employees involved in office romances disclose their relationship and follow key ground rules can help avoid negative impacts on the lab.
Model Workplace Romance & Fraternization Policy
It’s important to implement a policy that allows you to keep control over the potential issues romantic relationships can cause in the lab.
Courts Dismiss Two Whistleblower Lawsuits
In this month’s Labs in Court roundup, a medical device company and genetic testing company each win key victories.
