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Articles (266)

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1-10 of 266 results for FDA guidance

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Select article: An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees

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Research article

First published 2015-9

An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees

Jonathan Seltzer

Therapeutic Innovation & Regulatory Science

Select article: Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors

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Other

First published 2008-7

Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors

Mary Vanderhoof, Michael J. Umen, David N. Schwartz

Therapeutic Innovation & Regulatory Science

Select article: Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?

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Research article

First published 2017-11

Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?

Guido Freckmann, Annette Baumstark, Stefan Pleus

Journal of Diabetes Science and Technology

Select article: An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application

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Research article

First published 2019-3

An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application

Philip T. Lance, Ruth V. Greenaway, Brian Edwards

Therapeutic Innovation & Regulatory Science

Select article: Development of an FDA guidance document for clinical trials in SLE

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Research article

First published 1999-10

Development of an FDA guidance document for clinical trials in SLE

J N Siegel

Lupus

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

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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

Select article: Individual Bioequivalence—A Review of the FDA Draft Guidance

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Other

First published 1999-4

Individual Bioequivalence—A Review of the FDA Draft Guidance

Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

Select article: Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance

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Research article

First published 1996-10

Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance

Jen-pei Liu, Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

Select article: FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products

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Research article

First published 2022-09

FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products

Daniel Eisenman, Scott Swindle

Applied Biosafety

Select article: Recent Statistical Developments in Bioequivalence Trials — A Review of the FDA Guidance*

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Research article

First published 1994-7

Recent Statistical Developments in Bioequivalence Trials — A Review of the FDA Guidance*

Shein-Chung Chow, Jen-Pei Liu

Therapeutic Innovation & Regulatory Science

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