This article was originally published in RPM Report
The drug safety/user fee bill working its way through Congress has some surprising benefits for antibiotic drug developers, and a voucher scheme to let companies developing drugs for tropical diseases earn the right to faster FDA reviews for more commercially attractive products.
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The bill focuses on particularly virulent, resistant pathogens and also includes priority review designations and review of FDA guidelines.
FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data.
This is a reprint of the feature of the same title appearing in the July 2008 issue of The RPM Report.