File:Figure 5- Decrease in FDA First Cycle Review Time for Abbreviated New Drug Applications, Fiscal Years 2013 through 2015 (34728223774) (3).jpg
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![File:Figure 5- Decrease in FDA First Cycle Review Time for Abbreviated New Drug Applications, Fiscal Years 2013 through 2015 (34728223774) (3).jpg](https://upload.wikimedia.org/wikipedia/commons/thumb/a/a2/Figure_5-_Decrease_in_FDA_First_Cycle_Review_Time_for_Abbreviated_New_Drug_Applications%2C_Fiscal_Years_2013_through_2015_%2834728223774%29_%283%29.jpg/734px-Figure_5-_Decrease_in_FDA_First_Cycle_Review_Time_for_Abbreviated_New_Drug_Applications%2C_Fiscal_Years_2013_through_2015_%2834728223774%29_%283%29.jpg?20171223033858)
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[edit]DescriptionFigure 5- Decrease in FDA First Cycle Review Time for Abbreviated New Drug Applications, Fiscal Years 2013 through 2015 (34728223774) (3).jpg |
This image is excerpted from a U.S. GAO report: www.gao.gov/products/GAO-17-452 GENERIC DRUG USER FEES: Application Review Times Declined, but FDA Should Develop a Plan for Administering Its Unobligated User Fees Note: Approved: FDA issues an approval letter to an applicant when the agency has concluded its review of a generic drug application and the applicant is authorized to commercially market the drug. Tentatively approved: FDA issues a tentative approval letter when the agency has completed its review of an application, but patents or other exclusivities granted to the original, brand-name product prevent approval. A tentative approval letter does not allow the applicant to market the generic drug product until the related patents and other exclusivities no longer prevent approval. Complete response: FDA issues a complete response letter to an applicant at the completion of a full application review where deficiencies are found—the complete response letter describes any deficiencies that must be corrected in order for an application to be approved. |
Date | |
Source | Figure 5: Decrease in FDA First Cycle Review Time for Abbreviated New Drug Applications, Fiscal Years 2013 through 2015 |
Author | U.S. Government Accountability Office from Washington, DC, United States |
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This image is a work of an employee of the Government Accountability Office or a predecessor organization, taken or made as part of that person's official duties. As a work of the U.S. federal government, the image is in the public domain in the United States. | ![]() |
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This image was originally posted to Flickr by U.S. GAO at https://flickr.com/photos/58220939@N03/34728223774 (archive). It was reviewed on 23 December 2017 by FlickreviewR 2 and was confirmed to be licensed under the terms of the United States Government Work. |
23 December 2017
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current | 03:38, 23 December 2017 | ![]() | 2,347 × 1,918 (231 KB) | Artix Kreiger 2 (talk | contribs) | Transferred from Flickr via Flickr2Commons |
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