FDA Antibiotic Legislation Should Focus On Criteria, Not Bacteria, Woodcock Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Congress should allow the agency to determine which drug-resistant bacteria sponsors should target in order to earn incentives for antibiotic development, rather than list specific pathogens, CDER Director Janet Woodcock suggested to a House panel March 8. The window to change the GAIN Act appears to be closing, though.