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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.
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.
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]
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
An FDA building. The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.
Drug companies seeking to sell a drug in the United States must first test it. The company then sends the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) [3] evidence from these tests to prove the drug is safe and effective for its intended use. A fee is required to make such FDA submission.
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with ...
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 ...