The Evolution of FDA's Role in Ensuring Product Quality - Pharmaceutical Technology

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The Evolution of FDA's Role in Ensuring Product Quality
The quality of a drug product is an essential element of drug safety and efficacy. With a statutory mission to provide safe and effective medications to the public, the US Food and Drug Administration has always focused on drug quality. The authors summarize the history of FDA's role in ensuring product quality and its role in shaping risk-based approaches to this goal.


Pharmaceutical Technology


References

1. FDA, "Milestones in US Food and Drug Law History," (Aug. 2005), 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), http://www.fda.gov/opacom/backgrounders/problem.html (accessed June 7, 2007).

3. FDA, "Background and Definitions," http://www.fda.gov/oc/po/firmrecalls/recall_defin.html (accessed June 7, 2007).

4. FDA, "Medical Products Safety Information 2005," http://www.fda.gov/medwatch/safety.htm (accessed June 7, 2007).

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).

14. FDA, PAT—A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, Guidance for Industry (Aug. 2003), http://www.fda.gov/Cder/guidance/5815dft.htm (accessed June 7, 2007).

15. International Conference on Harmonization and US Food and Drug Administration, Q8: Pharmaceutical Development (Nov. 2005), http://www.ich.org/ (accessed June 7, 2007).

16. International Conference on Harmonization and US Food and Drug Administration, Q9: Quality Risk Management (November 2005), http://www.ich.org/ (accessed June 7, 2007).

17. International Conference on Harmonization and US Food and Drug Administration, Q10: Pharmaceutical Quality System (May 2007), http://www.ich.org/ (accessed June 7, 2007).

18. J. Woodcock, "Pharmaceutical Quality in the 21st Century—An Integrated Systems Approach," AAPS CMC Workshop, North Bethesda, MD, Oct. 2005.

19. Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington, DC, April 2001), Part 314.70.

20. D. C. Throckmorton, "Examining Drug Quality Regulation," Public Meeting on 21 CFR 314.70, Rockville, MD Feb. 2007.

21. FDA, "Innovation Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products," (March 2004), http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html (accessed July 19, 2007).


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