FDA Releases Draft Guidance on Antibacterial Drug Development

FDA Releases Draft Guidance on Antibacterial Drug Development

Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.

You can find that guidance at: http://www.fda.gov/downloads/Drugs/GuidanceCompliance.