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1

Jegen, Dominika A. Pharmaceutical safety withdrawals: A comparative study of the United States and Canada. Teneo Press, 2009.

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2

World Health Organization (WHO). Safety and security on the Internet: Challenges and advances in member states : based on the findings of the second global survey on eHealth. World Health Organization, 2011.

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3

System, Institute of Medicine (U S. ). Committee on the Assessment of the US Drug Safety. The future of drug safety: Promoting and protecting the health of the public. National Academies Press, 2007.

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4

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health. Drug safety: An update from the Food and Drug Administration : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, second session, March 10, 2010. U.S. G.P.O., 2012.

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5

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Federal and state role in pharmacy compounding and reconstitution: Exploring the right mix to protect patients : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Eighth Congress, first session, on examining state and federal oversight to ensure the safety and quality of drug compounding--the process of mixing, combining, or altering ingredients to create a customized medication for an individual patient--by pharmacies, October 23, 2003. U.S. G.P.O., 2004.

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6

Office, General Accounting. Drug safety: Most drugs withdrawn in recent years had greater health risks for women. U.S. General Accounting Office, 2001.

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7

United, States Congress Senate Committee on Governmental Affairs Subcommittee on Government Efficiency Federalism and the District of Columbia. Safety and soundness standards in the mail order prescription industry: Hearings before the Subcommittee on Government Efficiency, Federalism, and the District of Columbia of the Committee on Governmental Affairs, United States Senate, One Hundredth Congress, first session, August 5, 6, 1987. U.S. G.P.O., 1987.

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8

United, States Congress Senate Committee on Health Education Labor and Pensions. Drug importation: The realities of safety and security : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining the realities of safety and security regarding drug importation, February 16, 2005. U.S. G.P.O., 2005.

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9

Weinberg, Sandy. Cost-contained regulatory compliance: For the pharmaceutical, biologics, and medical device industries. John Wiley & Sons, 2011.

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10

Clinton, Bill. Reinventing regulation of drugs made from biotechnology. National Performance Review, 1995.

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11

Clinton, Bill. Reinventing regulation of drugs made from biotechnology. National Performance Review, 1995.

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12

Willig, Sidney H. Good manufacturing practices for pharmaceuticals: A plan for total quality control. 3rd ed. M. Dekker, 1992.

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13

Willig, Sidney H. Good manufacturing practices for pharmaceuticals: A plan for total quality control. 4th ed. Marcel Dekker, 1997.

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14

Willig, Sidney H. Good manufacturing practices for pharmaceuticals: A plan for total quality control from manufacturer to consumer. 5th ed. M. Dekker, 2001.

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15

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations. The adequacy of FDA to assure the safety of the nation's drug supply: Hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, February 13, March 22, 2007. U.S. G.P.O., 2007.

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16

McKoy, June M., and Dennis P. West, eds. Cancer Policy: Pharmaceutical Safety. Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-319-43896-2.

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17

Symposium on the Future of Drug Safety: Challenges for the FDA (2007 Washington, D.C.). Challenges for the FDA: The future of drug safety : workshop summary. National Academies Press, 2007.

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18

Haider, Syed Imtiaz. Validation standard operating procedures: A step-by-step guide for achieving compliance in the pharmaceutical, medical device, and biotech industries. 2nd ed. Taylor & Francis, 2006.

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19

1948-, Gore Albert, and National Performance Review (U.S.), eds. Reinventing the regulation of drugs made from biotechnology. National Performance Review, 1995.

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20

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. FDA's drug approval process: Up to the challenge? : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining Food and Drug Administration's (FDA) drug approval process, focusing on FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use, and that the drug meet [sic] meets standards for safety and efficacy, March 1, 2005. U.S. G.P.O., 2005.

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21

Herzyk, Danuta J., and Jeanine L. Bussiere, eds. Immunotoxicology Strategies for Pharmaceutical Safety Assessment. John Wiley & Sons, Inc., 2008. http://dx.doi.org/10.1002/9780470386385.

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22

J, Mulder Gerald, and Dencker L. 1957-, eds. Pharmaceutical toxicology: Safety sciences of drugs. Pharceutical Press, 2006.

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23

J, Herzyk Danuta, and Bussiere Jeanine L, eds. Immunotoxicology strategies for pharmaceutical safety assessment. John Wiley & Sons, 2008.

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24

Abramov, Yuriy A., ed. Computational Pharmaceutical Solid State Chemistry. John Wiley & Sons, Inc, 2016. http://dx.doi.org/10.1002/9781118700686.

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25

Office, New Zealand Audit. Department of Health: Safety and effectiveness of medicines. The Office, 1992.

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26

Byrn, Stephen R., George Zografi, and Xiaoming Sean Chen. Solid State Properties of Pharmaceutical Materials. John Wiley & Sons, Inc., 2017. http://dx.doi.org/10.1002/9781119264408.

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27

Gross, David. State pharmacy assistance programs. AARP Public Policy Institute, 1999.

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28

Storey, Richard A., and Ingvar Ymen. Solid state characterization of pharmaceuticals. John Wiley & Sons, 2011.

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29

Sally, Robinson, Pool Robert, Giffin Robert B, and Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation., eds. Emerging safety science: Workshop summary. National Academies Press, 2008.

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30

United States. Federal Emergency Management Agency., ed. Model state dam safety program. Federal Emergency Management Agency, 1998.

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31

Minnesota. Dept. of Human Services., ed. Feasibility study for a state-funded prescription drug assistance program: A report to the Minnesota State Legislature. Minnesota Dept. of Human Services, 1991.

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32

Schweitzer, Stuart O., and Z. John Lu. Pharmaceutical Regulation in the European Union. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190623784.003.0014.

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The main scientific and technical aspects of new drug registration, including pathways to marketing authorization approval, clinical study design and method, and requirement of and specifications for Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice, are all quite similar between Europe and the United States. Differences do exist, however. This chapter provides a closer examination of the drug regulatory regime in the European Union. After providing a brief history of the European Medicines Agency, the chapter examines the agency’s organizational structure and r
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33

Pray, Leslie A. Challenges for the FDA : The Future of Drug Safety: Workshop Summary. National Academies Press, 2007.

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34

Pray, Leslie A. Challenges for the FDA : The Future of Drug Safety: Workshop Summary. National Academies Press, 2007.

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35

Pray, Leslie A. Challenges for the FDA: The Future of Drug Safety, Workshop Summary. National Academies Press, 2007.

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36

Stoker, James R., and Sidney H. Willig. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control (Drugs and the Pharmaceutical Sciences Series, Vol 78). 4th ed. Marcel Dekker, 1996.

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37

Willig, Sidney H. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer (Drugs and the Pharmaceutical scienc. Marcel Dekker (E), 2000.

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38

Burke, Sheila P., Institute of Medicine, Kathleen Stratton, Board on Population Health and Public Health Practice, and Committee on the Assessment of the US Drug Safety System. Future of Drug Safety: Promoting and Protecting the Health of the Public. National Academies Press, 2007.

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39

Burke, Sheila P., Institute of Medicine, Kathleen Stratton, Board on Population Health and Public Health Practice, and Committee on the Assessment of the US Drug Safety System. Future of Drug Safety: Promoting and Protecting the Health of the Public. National Academies Press, 2007.

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40

Burke, Sheila P., Kathleen Stratton, Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice Staff, and Alina Baciu. Future of Drug Safety: Promoting and Protecting the Health of the Public. National Academies Press, 2007.

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41

Reputation and power organizational image and pharmaceutical regulation at the FDA. Princeton University Press, 2010.

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42

Directions for optimizing activities to ensure the quality and safety of medical care. Collection of materials. Remedium Privolzhje, 2020. http://dx.doi.org/10.21145/978-5-906125-80-4_2020.

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Editorial Board: Poklad L.A. — Doctor of Economics and Management, Director of the State Autonomous Establishment of Supplementary Professional Education of the Nizhny Novgorod region «Center for Advanced Training and Professional Retraining of Health Professionals», chief freelance specialist on nursing management of the Volga Federal District. Vagina E.V. — Candidate of Medical Sciences, Deputy Director of the State Autonomous Establishment of Supplementary Professional Education of the Nizhny Novgorod region «Center for Advanced Training and Professional Retraining of Health Professionals».
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43

Schweitzer, Stuart O., and Z. John Lu. Drug Approval Process in the United States. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190623784.003.0013.

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The drug approval process in any country involves a balancing of conflicting social objectives: safety and access. Faster approval leads to quicker access to potentially life-saving medicine, yet could also lead to false positives or, worse, unsafe products on the market. The United States has a widely respected but stringent and rigorous review process overseen by the Food and Drug Administration. This chapter performs an in-depth analysis of the pharmaceutical regulatory approval process in the United States. Standards, guidelines, and critical milestones for basic research, animal testing,
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44

Haider, Syed Imtiaz. Validation Standard Operating Procedures: Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries. Taylor & Francis Group, 2002.

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45

McKoy, June M., and Dennis P. West. Cancer Policy: Pharmaceutical Safety. Springer, 2018.

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46

Haider, Syed Imtiaz. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical. CRC, 2001.

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47

Haider, Syed Imtiaz. Validation Standard Operating Procedures. Taylor & Francis Group, 2019.

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48

Haider, Syed Imtiaz. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries. Taylor & Francis Group, 2006.

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49

Haider, Syed Imtiaz. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries. Taylor & Francis Group, 2006.

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50

Haider, Syed Imtiaz. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries. Taylor & Francis Group, 2010.

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