Image Purpose The Oncology Center of Excellence (OCE) Project Endpoint, begun in 2023, aims to enhance the development of endpoints in oncology drug development and foster […]

FDA is recruiting oncologists and hematologists to serve in the dynamic, highly challenging, and innovative atmosphere of oncology drug development and research. Who We Are [embedded […]

Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry 01/23/2020 11/05/2024   In Vitro Drug Interaction Studies — Cytochrome P450 […]

Patient questions and answers: Download and share Patients are at the heart of the FDA’s mission. The FDA protects public health by enforcing laws and regulations […]

Submit Comments by 01/14/2025 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-2016-D-1307 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research […]

Docket Number: FDA-2016-D-2285 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for […]

FDA has reevaluated data supporting cefiderocol breakpoints against Stenotrophomonas maltophilia. The review included data submitted to FDA under the cefiderocol new drug application, published literature, and […]

FDA Identified Breakpoints Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (zone diameters in mm) Pathogen S I R S I R Enterobacteralesa,b M-100 standard is recognized Pseudomonas […]