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Research article

First published 2009-8

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

M. E. Blair Holbein

Journal of Investigative Medicine

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Research article

First published 2019-7

Managing the Risks of Medicines: An Examination of FDA’s Application of Criteria for Requiring a REMS

Paul J. Seligman, Rebekah H. Anguiano, Thomas Felix [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019-9

Considering the Dynamics of FDA Human Factors Validation Requirement: Implications of Failure and Need to Ensure Project Success - A Conceptual Framework

Katia M. Rojas, Nasser Sharareh, Leon Cosier [...]

Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care

Free access

Research article

First published 2020-5

Evaluation of Precision and Bias Specifications Required to Achieve the 2018 FDA Guidance Criteria for Glucose Meter Performance Using Simulation Models

Andrew W. Lyon, Martha E. Lyon

Journal of Diabetes Science and Technology

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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Article commentary

First published 2008-05

The FDA Revises Requirements for Levothyroxine Products

Kenneth Burman, James Hennessey, Michael McDermott [...]

Thyroid®

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Editorial

First published 2011-11

FDA Reviews Narrow Therapeutic Index Requirement

J. Cada Dennis

Hospital Pharmacy

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Research article

First published 2019-9

A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool

Katia M. Rojas, Leon Cosler, Daryl L. Santos

Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care

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Research article

First published 1988-1

Acceptance of Foreign Clinical Data in Industry

Bernd Knabe

Therapeutic Innovation & Regulatory Science

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Other

First published 1999-7

Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

Larry R. Versteegh, Lynne M. Tracey

Therapeutic Innovation & Regulatory Science

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