MDUFA Negotiations Mellow Out Over Opposing Wish Lists
This article was originally published in The Gray Sheet
As FDA and industry struggle to align on reform priorities for a cost-conscious user-fee reauthorization proposal, the two sides took a step back to examine basic assumptions at a recent closed-door meeting.
You may also be interested in...
CDRH Director Jeff Shuren says FDA is willing to foot the bill for a coordinating center to help launch a new "national device evaluation system," but it is contingent on a guarantee that the program would be funded by the upcoming user fee reauthorization.
As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.
Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.