Gentamicin – Injection products
Exceptions or additions to the recognized standards. For the bacteria listed below, susceptibility test interpretive criteria are not recognized at this time:Acinetobacter spp.Other Non-Enterobacterales Content current as of: 10/23/2025...FDA Rational for Recognition: Gentamicin, Tobramycin, and Amikacin
FDA has completed its review of the rationale document titled, “Aminoglycoside Breakpoints for Enterobacterales and Pseudomonas aeruginosa” submitted by the Clinical and Laboratory Standards Institute (CLSI) to the public docket FDA-2017-N-5925-0037 in January...Fosfomycin Injection
S = Susceptible; I = Intermediate; R = Resistanta. Susceptibility interpretive criteria are based on a dose of 6 grams fosfomycin every 8 hours by intravenous infusion over 1 hour in patients with an estimated creatinine clearance of 50 mL/min.b. For disk diffusion,...Expanded Access to Investigational Drugs for Treatment Use: Q & A
Docket Number: FDA-2013-D-0446 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA is posting this document to provide advance notice to the public. After the lapse in appropriations ends, a notice of availability for the guidance will be...Patient-Focused Drug Development: Fit-for Purpose Clinical Assessments
Docket Number: FDA-2022-D-1385 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health FDA is posting this document to provide advance notice to the public....Guidance Recap Podcast
PodcastThank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this episode, I am excited to be talking with two people from FDA’s Center for Drug Evaluation and Research, Dr. David Reasner, the...Completed BsUFA II Deliverables
Best Practices for Communication Between IND Sponsors and FDA During Drug DevelopmentFinal Guidance Updated guidance on best practices for communication between IND sponsors and FDA during drug development.Meeting Management Goals12/29/2017BsUFA II: Assessment of the...CDER International Program
Contents: Mission and PurposeThe Center for Drug Evaluation and Research (CDER) has a mission to ensure the availability of safe and effective medicines to improve public health in the United States. Recognizing that pharmaceutical development, manufacturing, and...Click To Verify Security & Validation
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