Device Analysts See Tougher Mandates, More Recalls On Regulatory Horizon
This article was originally published in The Gray Sheet
Executive Summary
Device industry analysts say the FDA regulatory environment will get more challenging before eventually stabilizing, resulting in hazier pre-market requirements, tougher manufacturing inspections and more Class I recalls, among other burdens
You may also be interested in...
FDA, Industry Discuss Regulatory Impacts Of Infusion Pump Safety Steps
Imposing more stringent pre-market requirements on external infusion pumps may help reduce recalls, but could also slow market entry for safer pump designs, according to industry speakers at an FDA workshop
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.