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1

O'Reilly, James T. Food and drug administration. 2nd ed. [Eagan, MN]: Thomson/West, 2005.

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2

O'Reilly, James T. Food and drug administration. 2nd ed. [St. Paul, Minn.]: Thomson/West, 2005.

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3

O'Reilly, James T. Food and drug administration. 2nd ed. Colorado Springs, Colo: Shepard's/McGraw-Hill, 1993.

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4

The Food and Drug Administration. New York, N.Y: Chelsea House, 1988.

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5

A, Rettig Richard, Earley Laurence E, Merrill Richard A, and Institute of Medicine (U.S.). Division of Health Sciences Policy., eds. Food and Drug Administration advisory committees. Washington, D.C: National Academy Press, 1992.

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6

Center for Drug Evaluation and Research (U.S.), ed. Drugs@FDA. Washington D.C: U.S. Food and Drug Administration, Center for Drug and Evaluation Research, 2004.

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7

Buchta, Teresa M. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.

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8

United States. Food and Drug Administration. Cincinnati District Office and National Institute for Occupational Safety and Health, eds. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.

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9

Buchta, Teresa M. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.

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10

Philipson, Tomas J. Is the Food and Drug Administration safe and effective? Cambridge, Mass: National Bureau of Economic Research, 2007.

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11

ACG, McLaughlin Margaret, and Library of Congress. Congressional Research Service, eds. Drug approval: Access to experimental drugs for severely ill patients. [Washington, D.C.]: Congressional Research Service, Library of Congress, 1989.

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12

1942-, Cooper Richard M., and Food and Drug Law Institute (U.S.), eds. Food and drug law. Washington, D.C: Food and Drug Law Institute, 1991.

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13

Ceccoli, Stephen J. Pill politics: Drugs and the FDA. Boulder, Colo: Lynne Rienner Publishers, 2004.

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14

United States. Food and Drug Administration, ed. Public Health Service: Food and Drug Administration. [Rockville, Md: Food and Drug Administration, 1988.

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15

United States. Food and Drug Administration. History Office, ed. A guide to resources on the history of the Food and Drug Administration. Rockville, Md. (5600 Fishers Lane, Rockville 20857): Food and Drug Administration, History Office, 1995.

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16

FDA administrative enforcement manual. Boca Raton, FL: Taylor & Francis, 2005.

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17

1942-, Wallace Robert B., and Oria Maria, eds. Enhancing food safety: The role of the Food and Drug Administration. Washington, D.C: National Academies Press, 2010.

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18

Food and Drug Law Institute (U.S.), ed. Food and drug law and regulation. Washington, D.C: FDLI, 2008.

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19

US GOVERNMENT. Food and Drug Administration Modernization Act of 1997. [Washington, D.C.?: U.S. G.P.O., 1997.

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20

Yorke, Jeffrey. FDA ensures equivalence of generic drugs. [Rockville, MD] (5600 Fishers Lane, Rockville 20857): [Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Public Affairs, 1993.

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21

Yorke, Jeffrey. FDA ensures equivalence of generic drugs. [Rockville, MD] (5600 Fishers Lane, Rockville 20857): [Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Public Affairs, 1993.

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22

Pure food: Securing the Federal Food and Drugs Act of 1906. Princeton, N.J: Princeton University Press, 1989.

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23

United States. Food and Drug Administration. Requirements of laws and regulations enforced by the U.S. Food and Drug Administration. Rockville, MD: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, 1989.

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24

US GOVERNMENT. Compilation of laws enforced by the U.S. Food and Drug Administration and related statutes. Rockville, MD: The Administration, 1996.

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25

United States. Food and Drug Administration. Food and Drug Administration Modernization Act of 1997: FDA plan for statutory compliance. [Rockville, Md.]: FDA, 1998.

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26

Administration, United States Food and Drug. Food and Drug Administration Modernization Act of 1997: FDA plan for statutory compliance. [Rockville, Md.]: FDA, 1998.

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27

United States. Food and Drug Administration. Food and Drug Administration Modernization Act of 1997: FDA plan for statutory compliance. [Rockville, Md.]: FDA, 1998.

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28

United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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29

The Food and Drug Administration's critical mission and challenges for the future: Hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Tenth Congress, first session, May 1, 2007. Washington: U.S. G.P.O., 2007.

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30

United States. Food and Drug Administration. Office of Public Affairs., ed. FDA and the drug development process: How the agency ensures that drugs are safe and effective. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2002.

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31

Operations, United States Congress House Committee on Government. Human food safety and the regulation of animal drugs: Twenty-seventh report. Washington: U.S. G.P.O., 1986.

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32

United States. Congress. House. Committee on Government Operations. Human food safety and the regulation of animal drugs: Twenty-seventh report. Washington: U.S. G.P.O., 1986.

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33

United States. Congress. House. Committee on Government Operations. Human food safety and the regulation of animal drugs: Twenty-seventh report. Washington: U.S. G.P.O., 1986.

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34

Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

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35

Clinton, Bill. Reinventing regulation of drugs made from biotechnology. [Washington, D.C.?]: National Performance Review, 1995.

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36

Clinton, Bill. Reinventing regulation of drugs made from biotechnology. [Washington, D.C.?]: National Performance Review, 1995.

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37

1948-, Gore Albert, and National Performance Review (U.S.), eds. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

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38

Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

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39

Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

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40

Investigations, United States Congress House Committee on Energy and Commerce Subcommittee on Oversight and. FDA's foreign drug inspection program: Weaknesses place Americans at risk : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, April 22, 2008. Washington: U.S. G.P.O., 2008.

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41

Building a 21st century FDA: Proposals to improve drug safety and innovation : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, second session, on examining proposals to improve drug safety and innovation, and S. 3807, to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, November 16, 2006. Washington: U.S. G.P.O., 2007.

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42

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations. FDA's foreign drug inspection program: Weaknesses place Americans at risk : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, April 22, 2008. Washington: U.S. G.P.O., 2008.

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43

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations. FDA foreign drug inspection program: A system at risk : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, November 1, 2007. Washington: U.S. G.P.O., 2008.

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44

FDA foreign drug inspection program: A system at risk : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, November 1, 2007. Washington: U.S. G.P.O., 2008.

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45

FDA's foreign drug inspection program: Weaknesses place Americans at risk : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, April 22, 2008. Washington: U.S. G.P.O., 2008.

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46

United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee. FDA's regulation of the new drug Versed: Hearings before a subcommittee of the Committee on Government Operations, House of Representatives, One Hundredth Congress, second session, May 5 and 10, 1988. Washington: U.S. G.P.O., 1988.

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47

United States. Public Health Service, ed. FDA drug bulletin April 1970 through October 1990 ; FDA medical bulletin March 1991 through June 1993: Index by subject and title. Rockville, MD: Department of Health and Human Services, Public Health Service; Food and Drug Administration, Office of Public Affairs, 1993.

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48

D, Hynes Martin, ed. Preparing for FDA pre-approval inspections. New York: Marcel Dekker, 1999.

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49

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations., ed. Filthy food, dubious drugs, and defective devices: The legacy of FDA's antiquated statute : a staff report. Washington: U.S. G.P.O., 1991.

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50

United States. Food and Drug Administration. Food code: 1995 recommendations of the United States Public Health Service, Food and Drug Administration. Washington, D.C: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, 1995.

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