FDA List Of Potential Safety Signals Has 3 Pfizer Drugs, Echoes Drug Watch Site
FDA's quarterly report that lists potential signals of serious risks for drugs is similar in design to a program that the agency proposed and then withdrew following industry criticism
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A joint advisory committee will determine if regulatory action is necessary to reduce risks from intravenous administration of phenytoin and fosphenytoin, including the risk of a skin disease that can lead to amputation.
Agency’s acting chief scientist emphasizes need for communication “in the face of uncertainty” and rejects the “either/or” choice of personalized medicine versus comparative effectiveness.