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FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
Patrizia Cavazzoni was the director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). Prior to this position she worked at Pfizer and had been a psychiatrist. She resigned from FDA on January 10, 2025, ten days before Donald Trump took office. [3]
In 2002, the FDA transferred a number of biologically produced therapeutics to CDER. [8] CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the much brisker Center for Devices and Radiological Health.
Janet Woodcock (born August 29, 1948) is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). [2]
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Sue-Jane Wang is a biostatistician at the United States Food and Drug Administration (FDA), where she works as the Biostatistics Lead and as the liaison from the Office of Biostatistics to the FDA Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. She is also deputy division director for biometrics in the Office of ...
An FDA-approved medication already used to treat people who have type 2 diabetes and chronic kidney disease may also help lower their stroke and heart attack risk, a new study has found.
The Biomedical Advanced Research and Development Authority (BARDA) is a center within the Administration for Strategic Preparedness and Response [1] (ASPR) located within the U.S. Department of Health and Human Services (HHS) responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear ...