To Waive Or Not To Waive? Panel Presses For Simpler Blood Cell Counters
This article was originally published in The Gray Sheet
Executive Summary
The potential for less-sophisticated clinical laboratories to adopt automated blood cell counters remains uncertain after FDA's Hematology and Pathology Devices Panel suggested that simpler versions of the devices likely would be required
You may also be interested in...
FDA Says Final CLIA Waiver Guidance Eases Burdens; Industry Isn’t Satisfied
Final guidelines to companies developing point-of-care diagnostic tests for use in less sophisticated laboratories offer more leeway in clinical trial design than FDA initially proposed
As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.