Quality system survey
This article was originally published in The Gray Sheet
Executive Summary
Many device firms' quality management systems fail to adequately address safety issues associated with increasingly complex global supply chains, according to a survey of device industry professionals presented at the AdvaMed 2009 conference Oct. 12-14 in Washington, D.C. The study, conducted by quality management and compliance solutions provider Sparta Systems, found that 45% of firms feel their current quality systems are insufficient to mitigate compliance, risk and safety issues associated with supply chain management. In addition, 60% of companies have not begun preparing for FDA's electronic Medical Device Reporting mandate, proposed in August, which would require e-submission of post-market adverse events
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.