A Centennial Letdown for FDA's Biologics Group

Science  29 Nov 2002:
Vol. 298, Issue 5599, pp. 1704-1705
DOI: 10.1126/science.298.5599.1704

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New leaders at the Food and Drug Administration are pushing a big shakeup of the division that oversees biologics in a way that seems to de-emphasize research, although they cite other reasons for making changes. However, many researchers at the Center for Biologics Evaluation and Research and outside scientists have begun arguing that the real purpose of the move is to strip away CBER's special status as a regulator that also supports substantial intramural research.