Reform Bill Allows FDA Interim Data Reviews, Building Off Early IDE Meetings
This article was originally published in The Gray Sheet
Executive Summary
FDA would be authorized under HR 3580, "The Medical Device Amendments of 2001," to conduct premarket approval reviews of designated "priority" devices using interim data from clinical trials
You may also be interested in...
FDA Reform Bill Introduced Dec. 20 By Reps. Greenwood, Eshoo
Device-related FDA reform legislation will be pending in the House when the 107th Congress returns for its second legislative session in January
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.