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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 is 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
Clayton, Dubilier & Rice, LLC (CD&R) [1] is an American private equity company. CD&R is the 24th oldest Private Equity firm in the world. CD&R has managed the investment of more than $30 billion in approximately 90 businesses, representing a broad range of industries with an aggregate transaction value in excess of $140 billion.
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]
Lisa Morrissey LaVange (born 1953) is Professor and Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill where she directs the department’s Collaborative Studies Coordinating Center (CSCC), overseeing faculty, staff, and students involved in large-scale clinical trials and epidemiological studies ...
McLeod was a member of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Committee on Clinical Pharmacology from 2002 to 2013. He has also served in consultative roles for review of new drug applications for the Oncology Drugs Advisory Committee, the Gastrointestinal Advisory Committee, and Neurology section (carbamazepine-induced cutaneous adverse effects).
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.