The upheaval at the Food and Drug Administration appears to be taking a toll on the pharmaceutical industry, according to a new analysis of key agency metrics.
There was a significant drop in drug approvals in the recently ended third quarter, more marketing applications were rejected than in previous months, and the agency delayed more reviews of those applications, the analysis by RBC Capital Markets analysts found.
To wit, the rate of drug approvals was 73%, which was down from an average of 87% in the six previous quarters. The analysts also found the rate of rejected marketing applications reached 15%, up from what they termed an “historical average” of 10%. And the delay rate in meeting deadlines for completing application reviews hit 11%, up from an average of 4%.
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