ARTICLE | Regulation

Pathogen path still muddy

Why FDA proposals for antibiotic pathways don't go far enough for bad bugs

January 12, 2015 8:00 AM UTC

If FDA is trying to clarify the approval pathway for antibacterials to treat serious unmet needs, it's telling that companies are having trouble saying whether or when the agency's latest effort will make the process go faster or smoother.

The agency has spent at least three years trying to figure out how to dial back requirements it imposed on antibiotics developers in 2006 but now considers infeasible...