MIT, FDA team up on postmarket surveillance
This article was originally published in The Gray Sheet
Executive Summary
Massachusetts Institute of Technology's Center for Biomedical Innovation will work with FDA to explore real-time device and drug safety monitoring, Scott Gottlieb, FDA deputy commissioner for medical & scientific affairs, announced Aug. 17. MIT will identify alternative methods to monitor "well-established" pharmaceutical products and medical devices using "large healthcare datasets to recognize patterns that indicate unexpected efficacy or problems with safety," Gottlieb said. Such systems are currently being used to guard against bioterrorism and pandemics. Current methods to detect adverse events are insufficient, Gottlieb said...
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.