In Brief: Cholestech
This article was originally published in The Gray Sheet
Executive Summary
Cholestech: Files petition with the Centers for Disease Control and Prevention to reclassify the firm's total cholesterol, HDL cholesterol, triglycerides and glucose tests from the "moderately complex" to "waived" category under provisions of the Clinical Laboratory Improvements Amendments of 1988. CDC recently lifted its moratorium on processing in vitro diagnostic test waiver requests ("The Gray Sheet" Jan. 30, p. 4)...
You may also be interested in...
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.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.