November 5, 2019—The U.S. Food and Drug Administration’s office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part […]

On This Page Date: September 30, 2025 Time: 9:30 a.m. – 10:40 a.m. ET Location: Event Location White Oak Campus: The Great RoomFDA Headquarters 10903 New […]

On This Page Date: June 28, 2021 Time: 2:00 p.m. – 4:00 p.m. ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]

Docket Number: FDA-2024-N-5313Issued by: Center for Drug Evaluation and Research This is the list of guidances that CDER is considering for development during calendar year 2025. […]

FDA has completed their review of the rationale document titled, “Voriconazole Breakpoints for Aspergillus fumigatus” (FR01, May 2024), submitted by the Clinical and Laboratory Standards Institute […]

FDA has completed their review of the rationale document titled, “Piperacillin-Tazobactam Breakpoints for Enterobacterales” (MR14, February 2022), submitted by the Clinical and Laboratory Standards Institute (CLSI) […]

FDA has completed their review of the rationale document titled, “Piperacillin-Tazobactam Breakpoints for Pseudomonas aeruginosa” (MR15, January 2024), submitted by the Clinical and Laboratory Standards Institute […]

FDA has completed their review of the rationale document submitted by the Clinical Laboratory and Standards Institute (CLSI) to STIC Docket# FDA-2017-N-5925-023, entitled, “Cefazolin Breakpoints for […]

Cefazolin is a first-generation cephalosporin for parenteral administration that is indicated for the treatment of a number of bacterial infections including urinary tract infections. 1 In February […]