FDA Drug Approval:

Review Time Has Decreased in Recent Years

PEMD-96-1: Published: Oct 20, 1995. Publicly Released: Nov 7, 1995.

Additional Materials:

Contact:

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

Pursuant to a congressional request, GAO provided data on the Food and Drug Administration's (FDA) new drug application (NDA) process, focusing on: (1) whether the timeliness of the review and approval process for new drugs changed in recent years; (2) the factors that distinguish NDA that are approved quickly from those that take longer to approve; (3) what distinguishes NDA that are approved from those that are not; and (4) how FDA drug approval process compares with the approval process in the United Kingdom.

GAO found that: (1) the average number of months for NDA to be approved by FDA decreased from 33 months in 1987 to 19 months in 1992; (2) the overall decrease in approval times was achieved through gradual reductions in the submission of all NDA from 1987 to 1992; (3) the priority FDA assigns to an NDA and the experience of its sponsor determine the timeliness and likelihood of the approval process; and (4) although comparable data is limited, the review times for FDA and its counterpart agency in the United Kingdom are similar.

Sep 29, 2016

Sep 28, 2016

Sep 15, 2016

Sep 14, 2016

Sep 12, 2016

Sep 9, 2016

Sep 6, 2016

Looking for more? Browse all our products here