References
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http://www.fda.gov/opacom/backgrounders/miles.html (accessed June 7, 2007).
2. FDA, "How to Report Problems with Products Regulated by FDA," (Dec. 2006),
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3. FDA, "Background and Definitions,"
http://www.fda.gov/oc/po/firmrecalls/recall_defin.html (accessed June 7, 2007).
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5. FDA, "Medical Products Safety Information 2000,"
http://www.fda.gov/medwatch/safety.htm (accessed June 12, 2007).
6. United States Code, Title 21 (Durham-Humphrey Amendment, 1951), Section 301.
7. United States Code, Title 21 (Kefauver-Harris Amendment, 1962), Section 360.
8. Public Law 98–417 (Drug Price Competition and Patent Term Restoration Act, 1962).
9. United States Code, Title 21 (Prescription Drug User Fee Act, 1997), Section 310.
10. United States Code, Title 21 (Prescription Drug User Fee Amendments, 2002), Section 310.
11. Public Law 108–155 (Pediatric Research Equity Act, 2003).
12. Public Law 107–109 (Best Pharmaceuticals for Children's Act, 2002).
13. FDA, "Pharmaceutical CGMPS for the 21st Century—A Risk-based Approach: Second Progress Report and Implementation Plan,"
(2003),
http://www.fda.gov/cder/gmp/2ndProgressRept_Plan.htm (accessed June 12, 2007).
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http://www.ich.org/ (accessed June 7, 2007).
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http://www.ich.org/ (accessed June 7, 2007).
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19. Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington, DC, April 2001), Part
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20. D. C. Throckmorton, "Examining Drug Quality Regulation," Public Meeting on 21 CFR 314.70, Rockville, MD Feb. 2007.
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http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html (accessed July 19, 2007).
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