United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Program Evaluation and Methodology Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1996-05-02 monographic deposited born digital 17 p. GA 1.13:T-PEMD-96-9 https://www.govinfo.gov/app/details/GAOREPORTS-T-PEMD-96-9 P0b002ee18038e5b6 f:pe96009t DGPO 2010-08-12 2011-03-24 GAOREPORTS-T-PEMD-96-9 machine generated eng fdlp REPORT GAOREPORTS-T-PEMD-96-9 T-PEMD-96-9 Drugs Foreign governments Pharmacological research Product safety Consumer protection Regulatory agencies Food and drug law Pharmaceutical industry Safety regulation Product performance evaluation European Union United Kingdom Testimony PEMD 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. https://www.govinfo.gov/content/pkg/GAOREPORTS-T-PEMD-96-9/html/GAOREPORTS-T-PEMD-96-9.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-T-PEMD-96-9/pdf/GAOREPORTS-T-PEMD-96-9.pdf GAO/T-PEMD-96-9 https://www.govinfo.gov/app/details/GAOREPORTS-T-PEMD-96-9 Testimony GAO/T-PEMD-96-9; FDA Review Times; Drugs Foreign governments Pharmacological research Product safety Consumer protection Regulatory agencies Food and drug law Pharmaceutical industry Safety regulation Product performance evaluation European Union United Kingdom Public Law 102-571