FDA Fingerprints On MDUFMA Trigger? MDMA Holds Hill To Funding Targets
This article was originally published in The Gray Sheet
Executive Summary
A revision of the "trigger" within the Medical Device User Fee & Modernization Act to account for appropriations shortfalls would represent a breach of the original agreement by Congress, FDA and industry, the Medical Device Manufacturers Association contends
You may also be interested in...
McClellan’s “Strong FDA” Is Unfazed By Device Appropriations Shortfall
FDA is assuring medical device execs that the Bush Administration is united in seeking the additional appropriations required by MDUFMA, but cannot guarantee that funding benchmarks will be met by 2004
Executives On The Move: Changes At The Top At Enzolytics, Dyne Therapeutics And Seres Therapeutics
Recent moves in the industry include new chief financial officers at LENZ Therapeutics and Botanix Pharmaceuticals, plus new chief medical officers at Vigil Neuroscience and Voyager Therapeutics.
Israel's Gamida Cell Survives By Selling To Lender
Having finally secured US approval for Omisirge, Gamida was hoping to bag a strategic partner for the cell therapy. A year on, no suitable partner has been identified and the firm is delisting from the NASDAQ and going private.