Guidance In The Works For Unmet Need In Serious Bacterial Infections
Executive Summary
CHICAGO – FDA hopes to have a draft guidance for industry on developing antibiotics for serious bacterial infection with unmet medical need ready for public review in the first quarter of 2012, Edward Cox, director of FDA’s Office of Antimicrobial Products, told an audience at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago.
You may also be interested in...
FDA Emphasizes Pathogen ID In Complicated Intra-Abdominal Infection Guidance
The agency checked another box on the list of guidances anticipated by developers of antibiotic drugs with the Oct. 1 release of a draft guidance on treatments for complicated intra-abdominal infections.
FDA Continues To Clarify Antibiotic Requirements With New Guidance On Complicated UTI
A non-inferiority trial with a pre-specified non-inferiority margin is the most likely design for investigational antibacterial drugs targeted at cUTI, according to FDA draft guidance. Primary efficacy endpoint needs to include resolution of symptoms, on top of microbiological success.
Panel Gives Mixed Reviews To Using Single Trial For Community-Acquired Pneumonia
The Anti-Infective Drugs Advisory Committee's failure to agree on a preferred approval pathway for antibiotics to treat community-acquired bacterial pneumonia opens the door for FDA to offer several options to industry.