FDA List Of Potential Safety Signals Has 3 Pfizer Drugs, Echoes Drug Watch Site
Executive SummaryFDA'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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Under FDAAA, both centers are required to publish evaluations of AERS data. CBER’s review effort is more specialized, while CDER’s procedures are more centralized.