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1

Ensuring safe medicines and medical devices for children: Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007. Washington: U.S. G.P.O., 2008.

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2

Professor, O'Grady John, ed. Medicines, medical devices, and the law. London: Greenwich Medical Media, 1999.

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3

FDA regulation of medical devices. Buffalo Grove, IL: Interpharm Press, 1995.

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4

Harman, Robin J. Development and control of medicines and medical devices. London: Pharmaceutical press, 2004.

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5

United, States Congress House Committee on Small Business Subcommittee on Regulation Business Opportunities and Technology. Problems in securing informed consent of subjects in experimental trials of unapproved drugs and devices: Hearing before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, House of Representatives, One Hundred Third Congress, second session, Washington, DC, May 23, 1994. Washington: U.S. G.P.O., 1994.

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6

United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology. Problems in securing informed consent of subjects in experimental trials of unapproved drugs and devices: Hearing before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, House of Representatives, One Hundred Third Congress, second session, Washington, DC, May 23, 1994. Washington: U.S. G.P.O., 1994.

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7

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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8

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

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9

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

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10

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

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11

Chowdhury, Nupur. European Regulation of Medical Devices and Pharmaceuticals. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-04594-8.

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12

Lopez, Orlando. Data Integrity in Pharmaceutical and Medical Devices Regulation Operations. Boca Raton : CRC Press/Taylor & Francis, 2017.: Productivity Press, 2016. http://dx.doi.org/10.1201/9781315367095.

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13

Medical device safety: The regulation of medical devices for public health and safety. Bristol: Institute of Physics Pub., 2002.

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14

service), SpringerLink (Online, ed. Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines. Boston, MA: Springer Science+Business Media, LLC, 2011.

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15

Peck, Jonathan C. Regulating change: The regulation of food, drugs, medical devices, and cosmetics in the 1990s. [Washington, D.C: Food and Drug Law Institute], 1989.

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16

Termini, Roseann B. Life sciences law: Federal regulation of drugs, biologics, medical devices, foods, and dietary supplements. 3rd ed. Wynnewood, Pa: FORTI Publications, 2007.

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17

Life sciences law: Federal regulation of drugs, biologics, medical devices, foods, and dietary supplements. 4th ed. Wynnewood, Pa: FORTI Publications, 2010.

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18

United States. Food and Drug Administration, ed. Food and drug law: Federal regulation of drugs, biologics, medical devices, foods, dietary supplements, cosmetics, veterinary and tobacco products. 5th ed. Wynnewood, PA: FORTI Publications, 2012.

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19

Termini, Roseann B. Food and drug law: Federal regulation of drugs, biologics, medical devices, foods, dietary supplements, cosmetics, veterinary and tobacco products. Wynnewood, Pennsylvania?]: FORTI Publications, 2013.

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20

J, Pisano Douglas, and Mantus David, eds. FDA regulatory affairs: A guide for prescription drugs, medical devices, and biologics. 2nd ed. New York: Informa Healthcare USA, 2008.

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21

Altenstetter, Christa. Medical devices: European Union policymaking and the implementation of health and patient safety in France. New Brunswick, NJ: Transaction Pub., 2006.

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22

Altenstetter, Christa. Medical devices: European Union policymaking and the implementation of health and patient safety in France. New Brunswick, N.J: Transaction Publishers, 2008.

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23

United States. Food and Drug Administration, ed. Food and drug law: Federal regulation of drugs, biologics, medical devices, foods, dietary supplements, personal care, veterinary and tobacco products. Wynnewood, Pennsylvania?]: FORTI Publications, 2014.

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24

United States. Congress. Senate. Committee on Labor and Human Resources. Medical devices: Hearing before the Committee on Labor and Human Resources, United States Senate, One Hundred First Congress, second session, on examining proposed legislation to revise and strengthen the Food and Drug Administration's regulation of medical devices, July 25, 1990. Washington: U.S. G.P.O., 1991.

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25

Resources, United States Congress Senate Committee on Labor and Human. Medical devices: Hearing before the Committee on Labor and Human Resources, United States Senate, One Hundred First Congress, second session, on examining proposed legislation to revise and strengthen the Food and Drug Administration's regulation of medical devices, July 25, 1990. Washington: U.S. G.P.O., 1991.

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26

Feldschreiber, Peter. Law and Regulation of Medicines and Medical Devices. Oxford University Press, 2021.

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27

Feldschreiber, Peter. The Law and Regulation of Medicines and Medical Devices. 2nd ed. Oxford University Press, 2021. http://dx.doi.org/10.1093/oso/9780192847546.001.0001.

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This book focuses on the science and regulatory policy and law surrounding the discovery, development, and marketing of new medicines. It reviews consumer protection and intellectual property laws that are applicable to the development and commercialisation of medicinal products. It also provides a deeper understanding of the scientific and technical issues for lawyers and legal issues for those involved with regulatory policy and decision-making, such as senior executives in the pharmaceutical industry. The book covers the European and UK legislation on medicines and healthcare products together with the UK implementing legislation and instruments, and key case law. It discusses the structure and function of the regulatory authorities, applications to carry out clinical trials, intellectual property issues, product liability issues, and litigation.
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28

Britain, Great. Human Medicines and Medical Devices (Amendment etc. ) (EU Exit) Regulations 2019. Stationery Office, The, 2019.

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29

Britain, Great. Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2003. Stationery Office, The, 2003.

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30

Britain, Great. Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004. Stationery Office, The, 2004.

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31

Britain, Great. Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006. Stationery Office, The, 2006.

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32

Britain, Great. Human Medicines and Medical Devices (Amendment etc. ) (EU Exit) Regulations 2019. Stationery Office, The, 2019.

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33

Britain, Great. Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007. Stationery Office, The, 2007.

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34

The Medical Devices (Consequential Amendments - Medicines) Regulations 1994 (Statutory Instruments: 1994: 3119). Stationery Office Books, 1994.

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35

Britain, Great. Medicines for Human Use and Medical Devices (Fees Amendments) (No. 2) Regulations 2007. Stationery Office, The, 2007.

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36

Britain, Great. Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000. Stationery Office, The, 2000.

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37

Britain, Great. Medicines fees and charges: The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001. London: Stationery Office, 2001.

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38

Azam, Monirul. Intellectual Property and Public Health in the Developing World. Open Book Publishers, 2016.

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39

Chowdhury, Nupur. European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty. Springer, 2016.

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40

Chowdhury, Nupur. European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty. Springer London, Limited, 2014.

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41

European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty. Springer, 2014.

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42

Duttge, Gunnar. Tatort Gesundheitsmarkt: Rechtswirklichkeit - Strafwürdigkeit - Prävention. Universitätsverlag Göttingen, 2011.

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43

Britain, Great. Medicines and Medical Devices Act 2021 (Commencement No. 1 and Transitional and Savings Provision) Regulations 2021. Stationery Office, The, 2021.

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44

López, Orlando. Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance. Productivity Press, 2022.

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45

Britain, Great. The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999 (Statutory Instruments: 1999: 566). Stationery Office Books, 1999.

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46

Britain, Great. The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998 (Statutory Instruments: 1998: 574). Stationery Office Books, 1998.

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47

Medical Device Regulation. Taylor & Francis Group, 2021.

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48

Wreh, Elijah N. Medical Device Regulation: A Guidebook for Medical Device Manufacturers. Jenny Stanford Publishing, 2021.

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49

Wreh, Elijah N. Medical Device Regulation: A Guidebook for Medical Device Manufacturers. Jenny Stanford Publishing, 2021.

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50

Wreh, Elijah N. Medical Device Regulation: A Guidebook for Medical Device Manufacturers. Jenny Stanford Publishing, 2021.

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