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 Haemophilus influenzaand parainfluenzae M100 standard […]

Submit Comments by 09/20/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Docket Number: FDA-2013-D-0710 Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for […]

Looking for FDA-Recognized Susceptibility Test Interpretive Criteria? Looking for recent updates? Please see: Notices of Updates Sign up to receive FDA Recognized Antimicrobial STIC Breakpoints email […]

[6/20/2024] Today, FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” This draft guidance describes considerations regarding a switching […]

Docket Number: FDA-2017-D-0154 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]

FDA-approved biosimilars are safe and effective biologic medications that are highly similar to biologic medications already approved by FDA – called “reference products.” There are no […]

For Immediate Release: June 18, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]