Antiseptic products surrogate endpoints
Executive Summary
Microbiologic surrogate endpoints used to demonstrate the effectiveness of antiseptic products used in health care settings will be considered by FDA's Nonprescription Drugs Advisory Committee on March 23. Trial design, statistical issues and public health considerations will be discussed. The meeting will take place at the Hilton in Gaithersburg, Md. beginning at 8 a.m. [Editor's Note: To 1watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...
You may also be interested in...
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.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.