U. S. Food and Drug Administration • Center for Drug Evaluation and Research

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FDA Review Divisions Responsible for Oncology Products

A number of FDA organizational units have responsibility for reviewing products used by cancer patients. The Center for Drug Evaluation and Research (CDER) evaluates and regulates drugs; the Center for Biologics Evaluation and Research (CBER) evaluates and regulates biologicals; and the Center for Devices and Radiological Health evaluates and regulates devices.

  Phone Fax
CDER Oncology Drug Products (most drugs) 301-594-2473 301-594-0499
CBER Oncology Branch (for biologicals) 301-827-5093 301-827-5394
CDER Urologic and Reproductive Drug Products (for prostate cancer hormones) 301-827-4260 301-827-4267
CDER Radiopharmaceuticals and Medical Imaging 301-827-7510 301-443-9281
CDER Gastrointestinal and Coagulation Drug Products 301-827-7310 301-443-9285
CDER Anesthetic, Critical Care and Addiction Drug Products (most pain medications) 301-827-7410 301-443-7068
CDER Endocrine and Metabolic Drug Products 301-827-6430 301 443-9282
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Food Safety and Applied Nutrition (CFSAN)

Procedure for Filing a Single Patient IND (Compassionate or Emergency Use)

FDA/Center for Drug Evaluation and Research
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