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No Acceleration in Drug Approvals Despite ICT
Earlier research suggested that FDA review times decreased throughout the 1980s and into the 1990s, which was ascribed to greater resources and higher quality submissions as well as the PDUFA. However, increasing numbers of drug applications and increased concerns over drug safety, have to some extent negated the earlier gains in recent years.
"The FDA faces a balance between allocating resources between new drug reviews and the generic drug review process," the researchers say, "When more resources go to the new drugs, these new drugs can get to market faster and patients suffering from unsuccessfully treated diseases can benefit more quickly." Shorter drug review times can encourage new drug R&D, but more resources allocated to generic approvals can benefit the market and the consumer by offering more choice.
"The present research contributes a baseline for future comparison by which any future reductions in approval times which, do result from the implementation of information technology could be verified," the researchers conclude.
Source-Eurekalert
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