The Bureau of Biologics was established as a part of the FDA in 1972, after responsibility for monitoring the safety of vaccines, sera, and blood products was transferred from the NIH to the FDA. In 1982 the Bureau of Biologics was briefly merged with the FDA Bureau of Drugs to form the Center for Drugs and Biologics, but were split again in 1987, forming the current-day (2020) Center for Biologics Evaluation and Research (CBER). Today the CBER monitors the safety of biologics, vaccines, probiotics, blood products, and cell, tissue, and gene therapies, while the Center for Drug Evaluation and Research (CDER) has jurisdiction over protein-based therapies such as monoclonal antibodies.
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3.3 Douglas Richman: Antiviral Drug Resistance and Combination ART
(HIV/AIDS Research: Its History & Future Meeting)
... myself and Bob Chanock’s lab and Dave Barry (1944–2002), who was at the FDA Bureau of Biologics where we became friends. That's sort of how I got into AZT ... ...
Apr 27, 2021
... myself and Bob Chanock’s lab and Dave Barry (1944–2002), who was at the FDA Bureau of Biologics where we became friends. That's sort of how I got into AZT ... ...
Apr 27, 2021