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Research article

First published 1987-7

Postapproval Research Requested by the FDA at the Time of NCE Approval,1970–1984

Nancy Mattison, Barbara W. Richard

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-11

The Use of Real-World Evidence and Data in Clinical Research and Postapproval Safety Studies

Mary Jo Lamberti, Wayne Kubick, Josephine Awatin [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 1999-7

Product Quality Research Initiative and Bulk Actives Post Approval Change

Daniel H. Gold, Stephen Byrn

Therapeutic Innovation & Regulatory Science

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Other

First published 2009-9

Constant Vigilance: The Role of Pharmaceutical Companies in Medicine Safety

Gretchen S. Dieck, Susan Betger, Daniel A. Kracov [...]

Therapeutic Innovation & Regulatory Science

Free access

Article commentary

First published 2020-3

The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics

David C. Klonoff

Journal of Diabetes Science and Technology

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Research article

First published 2021-04

Regulating Generic Ophthalmologic Drug Bioequivalence—Envisioning Accessibility for Patients

Markham C. Luke, Darby Kozak

Journal of Ocular Pharmacology and Therapeutics

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Other

First published 2009-7

Assessing Medical Information Needs via an Internet-Based Survey

Stacey M. Fung, Laura Merriman, Maureen Cawley

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-1

Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes

Mary Jane Geiger, Cyrus Mehta, J. Rick Turner [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019

Statistical Methods for Clinical Study Site Selection

Jianjin Xu, Lan Huang, Zhihao Yao [...]

Therapeutic Innovation & Regulatory Science

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Meeting report

First published 2010-02

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report

Wallace P. Adams, Richard C. Ahrens, Mei-Ling Chen [...]

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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