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) […]

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 […]

Exceptions or additions to the recognized standards   Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Staphylococcus aureus ≤ 4 […]

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. […]

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 […]

Podcast Thank 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 […]

Best Practices for Communication Between IND Sponsors and FDA During Drug Development Final Guidance  Updated guidance on best practices for communication between IND sponsors and FDA […]