Evaluating the Pieces of the Pharma Supply Chain - Pharmaceutical Technology

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Evaluating the Pieces of the Pharma Supply Chain
After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region's short- and long-term role? This article contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 33, Issue 1

References

1. FDA, "Melamine Contamination in China" (Rockville, MD) Dec. 4, 2008, available at http://www.fda.gov/oc/opacom/hottopics/melamine.html, accessed Dec. 5, 2008.

2. FDA Release, "FDA Detects Melamine Contamination in Flavored Drink" (Rockville, MD), Oct. 6, 2008.

3. FDA, "Pet Food Recall (Melamine)/Tainted Animal Feed" (Rockville, MD), Feb. 6, 2008, available at http://www.fda.gov/oc/opacom/hottopics/petfood.html, accessed Dec. 5, 2008.

4. FDA, "Imported Toothpaste" (Rockville, MD) Oct. 9, 2007, available at http://www.fda.gov/oc/opacom/hottopics/toothpaste.html, accessed Dec. 5, 2008.

5. HHS, FDA Warning Letter to Ranbaxy Laboratories Limited, (Silver Spring, MD), Sept. 16, 2008.

6. PricewaterhouseCoopers, "The Changing Dynamics of Pharma Outsourcing in Asia: Are You Readjusting Your Sights?," (NY, New York), Oct. 2008.

7. P. Van Arnum, "Manufacturing Insights: Pfizer," Pharm. Technol. 32 (7), 50–52 (2008).

8. P. Van Arnum, "Outsourcing R&D in Asia: A Case Study of Pfizer," Pharm. Technol. 32 (8) Outsourcing Resources Suppl., s56–s62 (2008).

9. J. Lechleiter, "Innovation: The Cure for What Ails Us," speech at the Economic Club of Indiana, Sept. 24, 2008.

10. J. Dingell, F. Pallone, Jr., and B. Stupak, "Memorandum to the Members of the Committee on Energy and Commerce," US House of Representatives, Apr. 17, 2008.

11. US House Committee on Energy and Commerce, "Food and Drug Administration Globalization Act," Revised Discussion Draft, July 24, 2008 (Washington, DC).

12. J. Dingell, "Letter to Democratic Caucus" (Washington, DC), Nov. 6, 2008.

13. S. 3633, "Transparency in Drug Labeling Act," US Senate, 110th Congress, 2nd Session (Washington, DC), Sept. 26, 2008.

14. Interagency Working Group on Import Safety, "Import Safety—Action Plan Update, A Report to the President" (Washington, DC), July 1, 2008.

15. FDA, "Agreement between the Department of Health and Human Services of the USA and the State Food and Drug Administration of the People's Republic of China on the Safety of Drugs and Medical Devices" (Rockville, MD), Dec. 11, 2007.

16. HHS, "HHS Announces New International Programs to Enhance Drug and Food Safety" (Washington, DC), July 9, 2008.

17. ICH, Q10 Pharmaceutical Quality System (Geneva, Switzerland, June 2008), available at http://www.ich.org/cache/como/276-254-1.htm, accessed Dec. 10, 2008.


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
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