Guidance documents represent the Agency’s current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the […]

On This Page Date: September 24, 2025 Time: 9:00 a.m. – 12:00 p.m. ET The Food and Drug Administration (FDA) is holding a hybrid public meeting […]

The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: […]

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) […]