Docket Number: FDA-2015-D-3638 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical […]

Docket Number: FDA-2015-D-0198 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination […]

Docket Number: FDA-2011-D-0597 Issued by: Guidance Issuing Office Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center […]

Issued by: Guidance Issuing Office Center for Veterinary Medicine Human Foods Program Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for […]

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Office of the Commissioner Additional copies are available from:Office […]

Download the New NDC Express Mobile Application! Searching the NDC Directory is now faster and easier with our new mobile app! Download NDC Express Directorio de […]

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 […]