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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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.
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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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Public domain 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.
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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current03:38, 23 December 2017Thumbnail for version as of 03:38, 23 December 20172,347 × 1,918 (231 KB)Artix Kreiger 2 (talk | contribs)Transferred from Flickr via Flickr2Commons

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