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
FDA Tightens the Screws on EUA Review of COVID-19 Tests
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
M&A Report: Biosynex Looks to Snag Theradiag
A roundup of key mergers, acquisitions, and strategic asset purchases in the healthcare industry in September.
Qiagen Moves into Neurology with Recent Collaboration
The Hilden, Germany-based company is extending its genetic testing profile beyond oncology to neurology biomarkers.
FDA Sets New Limits on EUA Requests for COVID-19 Tests
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
Inadequate Reimbursement Threatens Monkeypox Lab Testing Response
ACLA and public health experts warn that current reimbursement rates will hamper US efforts to contain monkeypox spread.
LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour
Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.
CMS Sheds New Light on Proper Use of Modifier 59
Due to the common misuse of this modifier, the Centers for Medicare & Medicaid Services recently issued important new guidance on its proper use.
False Billing of Lab Tests and Two Dismissed Lawsuits
This month’s key lab cases involve false billing of urine drug and PGx tests and two lawsuits that were tossed.
Feds Lower the Boom on Home Sleep Test False Billing and Kickbacks
A recent $3.5 million settlement illustrates the kinds of pitfalls that can result in liability for hospital and freestanding sleep labs.
Feds Not Backing Away from Punishing CGx Testing Scams
Recent case shows that fraud and kickback schemes involving CGx testing continue to be on the federal enforcement radar.
