FDA Review Times

T-PEMD-96-9: Published: May 2, 1996. Publicly Released: May 2, 1996.

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GAO examined the Food and Drug Administration's (FDA) drug review and approval times, focusing on: (1) whether the timeliness of new drug reviews and approvals has changed; and (2) how approval times in the United States compare with those in the United Kingdom (UK). GAO found that: (1) new drug applications (NDA) are moving more quickly through the review and approval process; (2) the time taken for NDA approvals has decreased from 33 months in 1987 to 19 months in 1992; (3) the priority FDA assigns to NDA and the experience of application sponsors affect the timeliness of NDA decisions; (4) FDA assigns priority status to those applications expected to provide greater therapeutic relief; (5) NDA are approved 10 months faster than standard applications; (6) FDA made timely decisions on 67 percent of NDA between 1987 and 1993; (7) the on-time percentage for NDA is relatively stable and varies between a low of 62 percent to a high of 72 percent; (8) there is little relationship between the time FDA takes to reach a final decision and whether or not it meets a specific action deadline; (9) sponsors account for 20 percent of the time in NDA approval; (10) UK approval times are similar to the United States' and average 56 working days; (11) UK granted licenses for applications representing 32 new active substances during the 12-month period examined; and (13) it is too early to determine whether the European Union's new method of drug approval will ensure more efficient review while ensuring product safety.

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