FDA New Drug Approvals Down Significantly in 2016

CYNTHIA A. CHALLENER | January 2, 2017

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Following two years of near-record numbers of new drug approvals by FDA, with 41 in 2014 (1) and 45 in 2015 (2), 2016 appears to be seriously bucking the trend, with only 20 approvals issued as of Dec. 14, 2016 (3). The sharp decline was not expected. What might be the reasons? John Jenkins, director of FDA’s Office of New Drugs, attributed the difference to a decline in the number of submitted applications, more complete response letters in 2016, and the fact that five approvals originally scheduled for 2016 were finalized earlier in 2015 (4). On a positive note, Jenkins reported that the number of applications received by FDA through Dec. 9, 2016 was 36, surpassing the average number (35) of new molecular entity filings for the past decade.

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