The US Food and Drug Administration's tentative approval process and the global fight against HIV-Reference-Cited by-同舟云学术

The US Food and Drug Administration's tentative approval process and the global fight against HIV

Published:2017-12 Issue:4 Volume:20 Page:e25019
ISSN:1758-2652
Container-title:Journal of the International AIDS Society
language:en
Short-container-title:J Intern AIDS Soc

Author:

Chahal Harinder Singh¹^ORCID,Murray Jeffrey S²,Shimer Martin³,Capella Peter⁴,Presto Ryan³,Valdez Mary Lou⁵,Lurie Peter G¹

Affiliation:

1. Office of Public Health Strategy and Analysis; Office of the Commissioner; US Food and Drug Administration; Silver Spring MD

2. Office of New Drugs; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD

3. Office of Generic Drugs; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD

4. Office of Pharmaceutical Quality; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD

5. Office of International Programs; Office of the Commissioner; US Food and Drug Administration; Silver Spring MD

Publisher

Wiley

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/jia2.25019/fullpdf

Reference38 articles.

1. Joint United Nations Programme on HIV/AIDS (UNAIDS) Fact Sheet 2016 2016 http://www.unaids.org/en/resources/fact-sheet

2. Implementation science for the US President's Emergency Plan for AIDS Relief (PEPFAR);Padian;J Acquir Immune Defic Syndr,2011

3. United States Congress Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, in 22 U.S.C. 7601 2008 http://www.pepfar.gov/documents/organization/108294.pdf

4. Low-cost generic drugs under the President's Emergency Plan for AIDS Relief drove down treatment cost; more are needed;Venkatesh;Health Aff (Millwood),2012

5. US Food and Drug Administration Drugs@FDA Glossary of Terms - Tentative Approval 2012 http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#tentative

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