Kassa Ayalew

Infectious Disease

4921 Seminary Rd Ste 115
Alexandria, VA 22311

Last Updated: 09/26/2026

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Found 14 publications

Analyses of U.S. FDA GCP Assessments and Recommendations for Marketing Applications, 2015-2024.

Analyses of U.S. FDA GCP Assessments and Recommendations for Marketing Applications, 2015-2024.

Journal: Therapeutic innovation & regulatory science

Published: February 04, 2026

Lessons and Insights from a Case Study on Clinical Trial Fraud.

Lessons and Insights from a Case Study on Clinical Trial Fraud.

Journal: Therapeutic innovation & regulatory science

Published: November 18, 2025

Evolving Standards: Good Clinical Practice Insights from US FDA, MHRA UK, and Health Canada.

Evolving Standards: Good Clinical Practice Insights from US FDA, MHRA UK, and Health Canada.

Journal: Clinical pharmacology and therapeutics

Published: August 28, 2025

Modernizing Research and Evidence Consensus Definitions: A Food and Drug Administration-National Institutes of Health Collaboration.

Modernizing Research and Evidence Consensus Definitions: A Food and Drug Administration-National Institutes of Health Collaboration.

Journal: JAMA network open

Published: June 17, 2025

Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data.

Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data.

Journal: Therapeutic innovation & regulatory science

Published: March 05, 2025

Action for Increasing Diversity, Market Access, and Capacity in Oncology Registration Trials-Is Africa the Answer? Report From a Satellite Session of the Accelerating Anti-Cancer Agent Development and Validation Workshop.

Action for Increasing Diversity, Market Access, and Capacity in Oncology Registration Trials-Is Africa the Answer? Report From a Satellite Session of the Accelerating Anti-Cancer Agent Development and Validation Workshop.

Journal: JCO global oncology

Published: June 17, 2022

Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Journal: Therapeutic innovation & regulatory science

Published: June 06, 2022

Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Journal: Therapeutic innovation & regulatory science

Published: May 31, 2022

Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.

Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.

Journal: Therapeutic innovation & regulatory science

Published: May 17, 2022

Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Journal: Therapeutic innovation & regulatory science

Published: February 04, 2022

Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.

Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.

Journal: Clinical pharmacology and therapeutics

Published: April 09, 2021

Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.

Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.

Journal: Clinical pharmacology and therapeutics

Published: October 11, 2019

Showing 1-12 of 14

Last Updated: 09/26/2026