On this page, you will find information about: What is expanded access? Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious […]

Docket Number: FDA-2022-D-1981 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides information to applicants on how FDA intends to assign […]

Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa M100 standard is recognized Haemophilus influenzae and parainfluenzae M100 standard is […]

Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa M100 standard is recognized Acinetobacter spp. M100 standard is recognized Enterococcus […]

Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa M100 standard is recognized Acinetobacter spp. M100 standard is recognized Staphylococcus […]

Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa M100 standard is recognized Pseudomonas aeruginosa M100 standard is recognized Acinetobacter […]

Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa M100 standard is recognized Pseudomonas aeruginosa M100 standard is recognized Acinetobacter […]

Recognized Interpretive Criteria Additional FDA-identified interpretive criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa M100 standard is recognized […]

Recognized Interpretive Criteria Minimum Inhibitory Concentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa M100 standard is recognized Acinetobacter spp. M100 […]