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The FDA views PDUFA as An effective application given that the agency provides a consistent income stream for essential resources, the general public receives usage of remedies in a more immediate vogue, as well as the pharmaceutical industry has a more predictable product overview timeline.two Nonetheless, critics of PDUFA note that its existence may well possibly undermine public belief inside the FDA. These people today question whether or not the FDA can certainly be impartial and supply appropriate evaluate of drugs and biologics when industry dollars funds a substantial proportion of its spending plan; the FDA has collected $seven.sixty seven billion in user expenses from the sector due to the fact 1992.5 Other individuals place to postapproval medication safety concerns and advise the Act may well Enjoy a task in exposing individuals to medicines with considerable safety concerns mainly because of the “tension” to approve new prescription drugs and biologics previous to a PDUFA deadline.

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