Abbott's New Glucose Test Strips Are First To Address Fatal Product Flaw
This article was originally published in The Gray Sheet
Executive Summary
With a little extra push from FDA, Abbott gained 510(k) clearance May 14 for its new FreeStyle Lite blood glucose test strips, designed to remedy a potentially life threatening flaw in the product
You may also be interested in...
Regulatory News In Brief
Post-inspection response program: Beginning Sept. 15, FDA will consider industry responses to Form 483 inspection reports received within 15 days of the report's release when deciding whether to send a warning letter, FDA explains in an Aug. 11 Federal Register 1notice. Timely responses do not preclude FDA from issuing a warning letter. FDA Commissioner Margaret Hamburg announced the 15-day post-inspection deadline for company responses to FDA's inspection findings at a Food and Drug Law Institute meeting Aug. 6 (2"The Gray Sheet" Aug. 10, 2009). FDA plans to test out the response review program for 18 months and then decide whether to implement it permanently
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.