After Heparin: - The Pew Charitable Trusts
After Heparin: - The Pew Charitable Trusts
After Heparin: - The Pew Charitable Trusts
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219<br />
U.S. Food and Drug Administration. <strong>The</strong> Enforcement Story, Fiscal Year 2001. Chapter 6: Office of Criminal Investigation.<br />
http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106657.htm Accessed<br />
August 22, 2010.<br />
220<br />
Ibid.<br />
221<br />
Ibid.<br />
222<br />
Ibid.<br />
223<br />
U.S. Food and Drug Administration. <strong>The</strong> Enforcement Story, Fiscal Year 2005. Chapter 6: Office of Criminal Investigations.<br />
March 2006. http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/<br />
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224<br />
U.S. Food and Drug Administration. <strong>The</strong> Enforcement Story, Fiscal Year 2001. Chapter 6: Office of Criminal Investigation.<br />
http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm106657.htm Accessed<br />
August 22, 2010.<br />
225<br />
Lewis, Carol. FDA Investigators’ Reports—January–February 2002. FDA Consumer Magazine. January 4, 2002.<br />
226<br />
Ibid.<br />
227<br />
21 USC §331(j).<br />
228<br />
Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health<br />
Organ 2008; 86:749–756.<br />
229<br />
Ibid.<br />
230<br />
Schep, L.J., R.J. Slaughter, et al. Diethylene Glycol Poisoning. Clinical Toxicology. 2009. Vol. 47 No. 6.<br />
231<br />
Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health<br />
Organ, 2008, 86:749–756.<br />
232<br />
Rivera-Martinez, Edwin. Chief, Manufacturing Assessment and Preapproval Compliance Branch, Division of Manufacturing<br />
& Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration.<br />
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233<br />
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Origin of Contamination. Journal of Public Health Policy. 2009. Vol. 30, No. 2.<br />
234<br />
Rivera-Martinez, Edwin. Chief, Manufacturing Assessment and Preapproval Compliance Branch, Division of Manufacturing<br />
& Product Quality, Office of Compliance, Center for Drug Evaluation & Research, U.S. Food and Drug Administration.<br />
“Ensuring the Integrity of the Pharmaceutical Ingredient Supply Chain.” Presentation at the 2008 PDA/FDA Pharmaceutical<br />
Ingredient Supply Chain Conference, San Diego, Calif. December 1, 2008.<br />
235<br />
Schier, J.G., C.S. Rubin, et al. Medication-associated Diethylene Glycol Mass Poisoning: A Review and Discussion on the<br />
Origin of Contamination. Journal of Public Health Policy. 2009. Vol. 30, No. 2.<br />
236<br />
Rentz, E.D., L. Lewis, et al. Outbreak of Acute Renal Failure in Panama in 2006: a Case-Control Study. Bull World Health<br />
Organ, 2008, 86:749–756.<br />
237<br />
Ballentine, Carol. Taste of Raspberries, Taste of Death. <strong>The</strong> 1937 Elixir Sulfanilamide Incident. FDA Consumer, June 1981.<br />
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238<br />
Schep, L.J., R.J. Slaughter, et al. Diethylene Glycol Poisoning. Clinical Toxicology. 2009. Vol. 47 No. 6.<br />
239<br />
Ibid.<br />
240<br />
Bogdanich, Walt, and Jake Hooker. From China to Panama, a Trail of Poisoned Medicine. New York Times. May 6, 2007.<br />
http://www.nytimes.com/2007/05/06/world/americas/06poison.html?pagewanted=1. Accessed February 1, 2010.<br />
241<br />
O’Brien K.L., J.D. Selanikio, et al. Epidemic of Pediatric Deaths from Acute Renal Failure Caused by Diethylene Glycol<br />
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242<br />
Junod, Suzanne White. Diethylene Glycol Deaths in Haiti. Public Health Reports, January–February 2000, Vol. 115, No. 1.<br />
243<br />
Singh, J., A.K. Dutta, et al. Diethylene Glycol Poisoning in Gurgaon, India, 1998. Bull World Health Organ, 2001, 79:88–95.<br />
<strong>After</strong> <strong>Heparin</strong>: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 89