IMPACT  INNOVATION  PREDICTABILITY  ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2021 Director’s Message Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) annual report, […]

On This Page Date: July 23, 2024 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR (Hosted […]

On average, FDA determines that the vast majority of all expanded access requests may proceed. Sometimes called “compassionate use”, expanded access is a potential pathway for […]

For Post-Marketing Reports Drugs: FDA required that applicants electronically submit all ICSRs, ICSR attachments, and periodic safety reports. Refer to FDA Adverse Events Reporting System (FAERS) […]

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 […]