Search results: Sage Journals

Restricted accessResearch articleFirst published September, 2015

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

Jonathan Seltzer

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published July, 2008

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

Free accessResearch articleFirst published November, 2017

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

Restricted accessResearch articleFirst published March, 2019

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

Free accessResearch articleFirst published May, 2020

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

Restricted accessResearch articleFirst published October, 1999

Development of an FDA guidance document for clinical trials in SLE

J N Siegel

Lupus

Restricted accessOtherFirst published April, 1999

Individual Bioequivalence—A Review of the FDA Draft Guidance

Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1996

Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance

Jen-pei Liu, Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published July, 1994

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

Shein-Chung Chow, Jen-Pei Liu

Therapeutic Innovation & Regulatory Science

Free accessResearch articleFirst published September, 2022

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

Daniel Eisenman, Scott Swindle

Applied Biosafety

Restricted accessResearch articleFirst published September, 2015

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

Jonathan Seltzer

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published July, 2008

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

Free accessResearch articleFirst published November, 2017

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

Restricted accessResearch articleFirst published March, 2019

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

Free accessResearch articleFirst published May, 2020

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

Restricted accessResearch articleFirst published October, 1999

Development of an FDA guidance document for clinical trials in SLE

J N Siegel

Lupus

Restricted accessOtherFirst published April, 1999

Individual Bioequivalence—A Review of the FDA Draft Guidance

Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published October, 1996

Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance

Jen-pei Liu, Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published July, 1994

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

Shein-Chung Chow, Jen-Pei Liu

Therapeutic Innovation & Regulatory Science

Free accessResearch articleFirst published September, 2022

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

Daniel Eisenman, Scott Swindle

Applied Biosafety