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USA Today
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Tufts Center for the Study of Drug Development, press release, New Approaches to R&D May Prove Best Path for Drug Developers, April 6, 2010, available at http://csdd.tufts.edu/news/complete-story/rd-pr-april-2010 (last visited July 13, 2010).
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New Approaches to R&D May Prove Best Path for Drug Developers
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Outsourcing Strategies of Emerging Pharma
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Pharmaceutical Technology
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Navigating the Global Pharmaceutical Supply Chain
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Patricia Van Arnum, Navigating the Global Pharmaceutical Supply Chain, Pharmaceutical Technology, March 2, 2010, available at http://pharmtech. findpharma.com/pharmtech/Ingredients+Insider/Navigating-the-Global- Pharmaceutical-Supply-Chain/ArticleStandard/Article/detail/660521 (last visited July 13, 2010).
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Pharmaceutical Technology
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Pharmaceutical Technology
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Van Arnum, P.1
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Pharmaceutical Formulation & Quality
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Pharmaceutical Manufacturing
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David K. Cundiff, Letter-to-the Editor of the Journal of General Internal Medicine, January 2002, available at http://resources.metapress.com/pdf- preview.axd?code=d81201t603284876&size=largest (last visited July 13, 2010).
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Journal of General Internal Medicine
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The Heparin Story
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BioCentury
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Anon, March 2008, Heparin Crisis Rekindles Concern About Disease From Pig Transplants, available at http://www.animalpeoplenews.org/08/3/ heparincrisisrekindlesconcern0308.htm (last visited July 13, 2010).
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Heparin Crisis Rekindles Concern about Disease from Pig Transplants
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14
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Wall Street Journal
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Gordon Gibb, Heparin Counterfeit Seven Times Cheaper than the Real Thing, LawyersandSettlements.com, April 15 2008, available at http://www. lawyersandsettlements.com/articles/10432/heparin-counterfeit-cheaper.html (last visited July 13, 2010).
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Heparin Counterfeit Seven Times Cheaper Than the Real Thing
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Heparin Recall: Another Crisis for China & the FDA
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Susan Briones, Heparin Recall: Another Crisis for China & the FDA , University of Houston Health Law Perspectives, available at http://www.law.uh. edu/healthlaw/perspectives/2008/(SB)%20heparin.pdf (last visited July 13, 2010).
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Health Law Perspectives
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Morbidity and Mortality Weekly Report
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March available at last visited June 8, 2010
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Animal People, March 2008, Heparin Crisis Rekindles Concern About Disease From Pig Transplants, available at http://www.animalpeoplenews.org/08/3/ heparincrisisrekindlesconcern0308.htm (last visited June 8, 2010).
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Heparin Crisis Rekindles Concern about Disease from Pig Transplants
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Health Law Perspectives
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USP Monograph
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FDA Withholds List of Chinese Heparin Suppliers From Probe by Congress
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April available at last visited July 13, 2010
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FDA Warning Letter, April 2008, available at http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/ EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm054109. pdf (last visited July 13, 2010).
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FDA Warning Letter
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Bill Text 111th Congress (2009-10)
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Bill Text 111th Congress (2009-10)
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Christina Graffner, Swedish Medical Products Agency, Workshop: Quality by Design in pharmaceutical development and manufacture, March 28, 2006, available at http://www.ema.europa.eu/Inspections/docs/Presentations/SEMPA- ICHQ8PharmaceuticalDevelopment.pdf (last visited July 13, 2010).
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Federal Register
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Fiscal Year (FY) 2008 Enforcement Statistics Summary
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Letter from FDA Commissioner Margaret A. Hamburg to Senator Charles E. Grassley, March 4, available at last visited June 9, 2010
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