Sage Journals: Discover world-class research

Retricted access

Research article

First published 1997-1

Postapproval Changes in the United States—Is Life Getting Easier for Industry?

Helene Dumitriu

Therapeutic Innovation & Regulatory Science

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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

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

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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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Review article

First published 2014-12

Postapproval Clinical Experience in the Treatment of Dupuytren's Contracture with Collagenase Clostridium Histolyticum (CCH): The First 1,000 Days

Scott M. Schulze, James P. Tursi

HAND

Free access

Review article

First published 2013-10

Preparing for safety issues following drug approval: pre-approval risk management considerations

Gretchen S. Dieck, Robert G. Sharrar

Therapeutic Advances in Drug Safety

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Review article

First published 2025-04

Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory Considerations

Gur Jai Pal Singh, S. Prasad Peri

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Other

First published 2004-1

Pharmacoepidemiology in Safety Evaluations of Newly Approved Medications

Elane M. Gutterman

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-06

One-Year Postapproval Clinical Experience with Radium-223 Dichloride in Patients with Metastatic Castrate-Resistant Prostate Cancer

Hossein Jadvar, Sudha Challa, David I. Quinn [...]

Cancer Biotherapy and Radiopharmaceuticals

Open access

Research article

First published 2019-5

DuraSeal Exact Is a Safe Adjunctive Treatment for Durotomy in Spine: Postapproval Study

Kee D. Kim, Dinesh Ramanathan, Jason Highsmith [...]

Global Spine Journal

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