After Heparin: - The Pew Charitable Trusts

REFERENCES
378
Villax, Guy. Board Member of the European Fine Chemicals Group and Rx-360; CEO, Hovione. Direct communication.
February 22, 2010.
379
Basu, Prabir. Executive Director, National Institute for Pharmaceutical Technology and Education. Direct communication,
December 17, 2009.
380
André, Philippe. Director, Qualiau Pharmaceutical Auditing Co., Ltd.; Associate Professor, School of Pharmaceutical
Science and Technology, Tianjin University. Direct communication, March 8, 2010.
381
U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA’s
Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
382
U.S. Government Accountability Office (September 2010). Drug Safety: FDA Has Conducted More Foreign Inspections and
Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publication No. GAO-10-961).
383
Ibid.
384
U.S. Food and Drug Administration. “FDA Science and Mission at Risk.” Report of the Subcommittee on Science and
Technology, November 2007.
385
U.S. Government Accountability Office (September 2010) U.S. Food and Drug Administration: Overseas Offices Have
Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed (Publication No. GAO-10-960).
386
Ibid.
387
Ibid.
388
U.S. Food and Drug Administration. “Revitalizing ORA: Protecting the Public Health Together in a Changing World.”
Rockville, Md.: January 2008.
389
Ibid.
390
U.S. Government Accountability Office (November 2007). Drug Safety: Preliminary Findings Suggest Weakness in FDA’s
Program for Inspecting Foreign Drug Manufacturers (Publication No. GAO-08-224T).
391
Ibid.
392
Ibid.
393
Ibid.
394
Laipson, Elizabeth. FDA Answers IT Wake-up Call. Government Health IT, a publication of HiMSS Federal Health
Community, November 20, 2009. http://govhealthit.com/news/fda-answers-it-wake-call-0. Accessed November 23, 2009.
395
21 USC §355 (b)(1)(D).
396
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guideline for Submitting Supporting
Documentation in Drug Applications for the Manufacture of Drug Products. http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM149698.pdf. Accessed August 16, 2010.
397
21 CFR §211.184.
398
U.S. Food and Drug Administration. Protecting Patients: FY 2011 Congressional Justification with summary table. http://
www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM205622.pdf. Accessed May 2,
2011.
399
U.S. Food and Drug Administration. FDA Regulatory Procedures Manual. Chapter 9: Import Operations and Actions.
http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179264.htm. Accessed January 26, 2011.
400
Nielsen, Carl. Statement before the Subcommittee on Oversight and Investigations, Committee on Energy and
Commerce, U.S. House of Representatives. November 1, 2007.
401
Ibid.
402
Skud, Timothy E. Deputy Assistant Secretary for Tax, Trade, and Tariff Policy, U.S. Department of the Treasury. Testimony
before the Subcommittee on Trade, Committee on Ways and Means, U.S. House of Representatives. Hearing on Customs
Trade Facilitation and Enforcement in a Secure Environment. May 20, 2010. http://waysandmeans.house.gov/media/
pdf/111/2010May20_Skud_Testimony.pdf. Accessed November 14, 2010.
403
Kelley, Colleen M. National President, National Treasury Employees Union. Testimony before the Subcommittee On Trade,
Committee On Ways And Means, U.S. House of Representatives. Hearing on Customs Trade Facilitation and Enforcement
in a Secure Environment. May 20, 2010.
96
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