US set to update PMA (pre-market approval) rule
This article was originally published in Clinica
Executive Summary
The US FDA is considering whether to update the regulation that permits companies to use foreign clinical trials results in premarket approval (PMA) applications. The current position of the agency is that it will accept foreign clinical study data (that is not part of an investigational device exemption) if: they conform to the ethical principles contained in the 1989 version of the Helsinki Declaration; or they provide greater protection for humans, to the laws and regulations of the country in which the research was conducted. .
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.