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Articles (39)

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1-10 of 39 results for preapproval

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Select article: The Food and Drug Administration Office of Compliance's Role in the Preapproval Process

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Research article

First published 1993-4

The Food and Drug Administration Office of Compliance's Role in the Preapproval Process

Paul Vogel

Therapeutic Innovation & Regulatory Science

Select article: Value of preapproval safety data in predicting postapproval hepatic safety and assessing the legitimacy of class warning

Free access

Research article

First published 2012-2

Value of preapproval safety data in predicting postapproval hepatic safety and assessing the legitimacy of class warning

Yeong-Liang Lin, Ya-Chi Wu, Churn-Shiouh Gau [...]

Therapeutic Advances in Drug Safety

Select article: Preapproval Access and Right-to-Try Initiatives

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Research article

First published 2017-3

Preapproval Access and Right-to-Try Initiatives

Art Gertel

Therapeutic Innovation & Regulatory Science

Select article: Preapproval Promotion: FDA'S View

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Other

First published 1989-10

Preapproval Promotion: FDA'S View

Kenneth R. Feather

Therapeutic Innovation & Regulatory Science

Select article: Marketing Issues in the Preapproval Stage

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Other

First published 1989-10

Marketing Issues in the Preapproval Stage

Gail R. Safian

Therapeutic Innovation & Regulatory Science

Select article: How the FDA Regulates Drug Promotion and Medical Education before Drug Approval

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Other

First published 1989-10

How the FDA Regulates Drug Promotion and Medical Education before Drug Approval

William W. Vodra

Therapeutic Innovation & Regulatory Science

Select article: Preapproval of Sinus Computed Tomography for Evaluation of Chronic Rhinosinusitis Does Not Save Healthcare Costs

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Other

First published 2013-9

Preapproval of Sinus Computed Tomography for Evaluation of Chronic Rhinosinusitis Does Not Save Healthcare Costs

Ahmad R. Sedaghat, Stacey T. Gray, David A. Kieff

Otolaryngology–Head and Neck Surgery

Select article: Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity

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Other

First published 2008-1

Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity

Yeong-Liang Lin

Therapeutic Innovation & Regulatory Science

Select article: Auditor-Provided Tax Services and Earnings Management in Tax Expense

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Research article

First published 2014-7

Auditor-Provided Tax Services and Earnings Management in Tax Expense

Ling Lei Lisic

Journal of Accounting,Auditing & Finance

Select article: Improving Expanded Access in the United States

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Research article

First published 2018-5

Improving Expanded Access in the United States

Kelly McBride Folkers, Alison Bateman-House

Therapeutic Innovation & Regulatory Science

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