FDA expands scope of genetic testing regulations
This article was originally published in Clinica
Executive Summary
The US FDA is preparing a notice of proposed rulemaking that would expand the its oversight of genetic testing. The notice, which is still "being worked on and resolved", would require the premarket review of some of the reagents used for genetic testing, explained Steven Gutman, director of the office of in vitro diagnostic device evaluation and research within the device centre (CDRH).
You may also be interested in...
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.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.