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Home » Use of Expedited Approval Pathways Continues Upward Trend, FDA Study Shows
Use of Expedited Approval Pathways Continues Upward Trend, FDA Study Shows
Use of FDA’s expedited approval pathways for new drugs increased from 42 percent in 2008 to more than 75 percent in 2021 — an increase that’s likely to continue as innovative biologic therapies targeting rare diseases seek marketing approval, according to a team of senior FDA officials that recommends the agency exercise caution in speeding new drug approvals.