FDA unveils plan to strengthen its drug safety program.(News)
Publication: Internal Medicine News
Publication Date: 15-DEC-04
Author: Mechcatie, Elizabeth
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In the wake of the withdrawal of rofecoxib and the addition of a black box warning for antidepressants, the Food and Drug Administration last month announced a plan aimed at strengthening its safety program for drugs.
A main component of the plan is an FDA-sponsored study by the Institute of Medicine that will evaluate the current drug safety system, with emphasis on the postmarketing phase. The IOM study will assess what additional steps could be taken to learn more about the adverse effects of drugs once they are on the market. The FDA also plans to create a system to adjudicate differences of professional opinion within its Center for Drug Evaluation and Research (CDER) concerning a particular drug, a situation...
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