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Even as new drug approvals have been consistently increasing, the rate of market withdrawals for safety reasons has been decreasing for well over a decade. The chart on this page illustrates that 3.2 percent of drugs were withdrawn in the 1979-1983 time span, 3.5 percent in 1984-1988, 1.6 percent in 1989-1993, and only 1.2 percent in 1994-1998 (years with the Prescription Drug User Fee Act in place). ("New drug" refers to molecular entities, or products with an active substance not previously marketed in the United States.)


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