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Articles (105)

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1-10 of 105 results for postmarketing requirements

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Select article: US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments,2009–2018

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Research article

First published 2021-8

US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments,2009–2018

Joshua J Skydel, Audrey D Zhang, Sanket S Dhruva [...]

Clinical Trials

Select article: Regulatory Considerations regarding International Post-Marketing Surveillance

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Other

First published 1985-7

Regulatory Considerations regarding International Post-Marketing Surveillance

William W. Vodra

Therapeutic Innovation & Regulatory Science

Select article: The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

Select article: The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

Select article: Postmarketing Safety Administration in Japan

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Other

First published 1994-4

Postmarketing Safety Administration in Japan

Kazuo Hirayama

Therapeutic Innovation & Regulatory Science

Select article: Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making,2016–2024

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Research article

First published 2026

Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making,2016–2024

Louis Y Li, Reshma Ramachandran, Joseph S Ross [...]

Clinical Trials

Select article: Postmarketing Surveillance Studies: Practical Issues in Design and Management

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Research article

First published 1994-7

Postmarketing Surveillance Studies: Practical Issues in Design and Management

Cynthia Lauber-Huber

Therapeutic Innovation & Regulatory Science

Select article: Adverse Reaction Reporting Requirements: An Update for Manufacturers *

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Research article

First published 1990-1

Adverse Reaction Reporting Requirements: An Update for Manufacturers *

Thomas H. Perez

Therapeutic Innovation & Regulatory Science

Select article: Pharmacogenomic Testing and Regulation: The Role of Pharmacogenomics in Pharmaceutical Development and the Regulation of Pharmacogenetic Test as in Vitro Diagnostics *

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Other

First published 2006-1

Pharmacogenomic Testing and Regulation: The Role of Pharmacogenomics in Pharmaceutical Development and the Regulation of Pharmacogenetic Test as in Vitro Diagnostics *

David Jefferys, David Atkins, Andy Bufton [...]

Therapeutic Innovation & Regulatory Science

Select article: Impact of FDA-Required Cardiovascular Outcome Trials on Type 2 Diabetes Clinical Study Initiation From 2008 to 2017

Open access

Research article

First published 2019

Impact of FDA-Required Cardiovascular Outcome Trials on Type 2 Diabetes Clinical Study Initiation From 2008 to 2017

Cameron M. Kieffer, Andrew S. Robertson

Therapeutic Innovation & Regulatory Science

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