Long-Awaited CLIA Waiver Guidance To Be Issued Mid-Year – FDA
This article was originally published in The Gray Sheet
Executive Summary
Outgoing Clinical Laboratory Improvement Advisory Committee Chair David Sundwall, MD, is pressing FDA to expedite publication of the agency's CLIA-waiver guidance
You may also be interested in...
Clinical Lab Association’s Sundwall Will Head Utah Health Department
The American Clinical Laboratory Association is seeking a senior medical and scientific officer to coordinate CLIA and CPT coding policy issues after the departure of David Sundwall, MD/PhD
FDA Draft Guidance Will Aim To Increase CLIA Waiver Flexibility
FDA plans to release a CLIA waiver draft guidance by year end, according to the Office of In Vitro Diagnostic Devices Evaluation & Safety
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.