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Pharmaceutical Economics and PolicyPerspectives, Promises, and Problems$
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Stuart O. Schweitzer and Z. John Lu

Print publication date: 2018

Print ISBN-13: 9780190623784

Published to Oxford Scholarship Online: May 2018

DOI: 10.1093/oso/9780190623784.001.0001

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Drug Approval Process in the United States

Drug Approval Process in the United States

(p.323) 12 Drug Approval Process in the United States
Pharmaceutical Economics and Policy

Stuart O. Schweitzer

Z. John Lu

Oxford University Press

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, and clinical trials in the drug R&D process are explained. It highlights major drug legislation since the beginning of the twentieth century and how this legislation has helped the FDA become the gold standard in pharmaceutical regulation worldwide. The registration pathways for generics and biosimilars are also discussed.

Keywords:   FDA, clinical trials, New Drug Application, post-approval research, cost

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