> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Half as Many New Drugs Approved in 2016 as in 2015
- URL: https://www.fdaweb.com/half-as-many-new-drugs-approved-in-2016-as-in-2015/
- Published: 2017-01-03T12:00:00.000Z
- Updated: 2026-09-14T21:56:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137624

CDER saw a dramatic drop in innovative new drug approvals in 2016 — just 22 approved ([see listing here](http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm?ref=fdaweb.com)) which is half as many as were approved in 2015\. In his last [annual review](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM533192.pdf?ref=fdaweb.com) of the Center’s approval performance presentation before retiring, Office of New Drugs director **John Jenkins** said last month that the agency was now issuing more complete response letters than before. Additionally, fewer new molecular entity submissions were received during 2016 and five applications that were targeted for approval in 2016 but instead received early approvals at the end of 2015 contributed to the approval decline. Overall, CDER’s approval action rate had fallen from 96% in 2015 to 61% projected with just two weeks left in the calendar year when Jenkins delivered his update. 

Complete response letters have skyrocketed from two issued in 2015 to 12 in 2016, with several due to manufacturing-related issues holding up approval, according to Jenkins’ stats. Approval times this year show positive improvement — landing at 7.8 months (overall NME NDA/BLAs median total time to approval), which is the lowest since the user fee program began in 1993.

 Jenkins noted that CDER continued to ensure the efficiency of first cycle review, and all but one (95%) of the novel drugs approved in 2016 met their user fee goal dates. Additionally, almost all (95%) of the novel drugs approved were approved in the first review cycle.