FDA's Young on Delaney
Executive Summary
In a discussion of the increased burden on the agency related to food "scares" such as the recent uproar over trace amounts of Alar in apples, FDA Commissioner Young told the House Appropriations/Agriculture Subcommittee at an April 10 hearing that Congress must "deal with the Delaney issue." He also cited FD&C Red 3 as an example of the "terrible problem" caused by the Delaney Clause. Under a de minimis analysis, the color additive is "safe," Young said, while a rigid interpretation of the law appears to dictate otherwise.
You may also be interested in...
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.
Cidara Offloads Rezzayo, Will Focus On Universal Flu Preventative
Cidara conferred global rights to its novel antifungal to marketing partner, Mundipharma, while reacquiring a flu prophylaxis it licensed to J&J in 2021 and gaining $240m in new funding to back development.