FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Essential
Subscribe today for access to
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
Inside the Industry: Government Report Casts Doubt on Cost-Effectiveness of Leading Genetic Colorectal Cancer Screening Test
From - Laboratory Industry Report
Few of the newfangled consumer genetic testing products have had greater commercial success and…
Medicare Reimbursement: MIPS Bonuses Are Easy to Earn, IF You Can Get into the Program
From - Lab Compliance Advisor
On July 11, CMS announced the results of 2018, Year 2 under the Merit-based Incentive Payment System…
Already a member? Log in here
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From - National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
Are Erratic Scheduling Practices Causing Financial Instability for Your Hourly Lab Employees?
From - Laboratory Industry Report
A study reveals that for today's hourly workforce, missing a single shift comes at a steep cost…
Already a member? Log in here
Explaining the Legal News: Why ACLA Court Win Boosts Chances of PAMA Pricing Relief
From - Lab Compliance Advisor
By now, you've no doubt heard the news that the American Clinical Laboratory Association (ACLA) "won" its lawsuit against…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here's a summary of the key product launches announced from late July through the third week of…
Already a member? Log in here
Stark Law: CMS Plan Would Make It Easier for Labs to Get Advisory Opinions
...
Already a member? Log in here