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 1995-10-20 monographic deposited born digital 50 p. GA 1.13:PEMD-96-1 https://www.govinfo.gov/app/details/GAOREPORTS-PEMD-96-1 P0b002ee18038fa9b f:pe96001 DGPO 2010-08-12 2011-03-24 GAOREPORTS-PEMD-96-1 machine generated eng fdlp REPORT GAOREPORTS-PEMD-96-1 PEMD-96-1 Pharmaceutical industry Pharmacological research Drugs Regulatory agencies Food and drug law Comparative analysis Safety regulation Consumer protection Product safety Foreign governments United Kingdom Other Written Product PEMD

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.<p/>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. https://www.govinfo.gov/content/pkg/GAOREPORTS-PEMD-96-1/html/GAOREPORTS-PEMD-96-1.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-PEMD-96-1/pdf/GAOREPORTS-PEMD-96-1.pdf GAO/PEMD-96-1 https://www.govinfo.gov/app/details/GAOREPORTS-PEMD-96-1 Other Written Product GAO/PEMD-96-1; FDA Drug Approval: Review Time Has Decreased in Recent Years; Pharmaceutical industry Pharmacological research Drugs Regulatory agencies Food and drug law Comparative analysis Safety regulation Consumer protection Product safety Foreign governments United Kingdom Title 21 Section 355 21 U.S.C. 355 Public Law 102-571