Biopharmaceutical Compliance

doi:10.1017/9781108759458.062

62 - Biopharmaceutical Compliance

from Part IX - Analysis of Particular Fields

Published online by Cambridge University Press: 07 May 2021

Jordan Paradise

Edited by

Benjamin van Rooij and

D. Daniel Sokol

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Benjamin van Rooij: Affiliation:
School of Law, University of Amsterdam
D. Daniel Sokol: Affiliation:
University of Florida

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Summary

Abstract: The global pharmaceutical market is projected to approach $1170 billion by the year 2021; the US market alone currently accounts for 45 percent of the market, at nearly $500 billion. International legal frameworks share fundamental characteristics governing the development, evaluation, and approval of drugs and biological products, including clinical trials demonstrating safety and efficacy; good laboratory, clinical, and manufacturing practices; appropriate labeling; and robust reporting and post-market surveillance. This chapter explores regulatory compliance in the pharmaceutical industry drawing from recent scholarship, federal agency reports and materials, and publicly available corporate resources. Coverage will focus specifically on the US market, with general discussion of international trends as well.

Type: Chapter
Information: The Cambridge Handbook of Compliance , pp. 909 - 923

DOI: https://doi.org/10.1017/9781108759458.062 [Opens in a new window]

Publisher: Cambridge University Press

Print publication year: 2021

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