REDI™ - Regulatory, Equity, Diversity & Inclusion Action Plans

• The Evolution of Decentralized Clinical Trials: Blending Innovation and Regulation in the Digital Age

October 2024

• FDA-Guidance-E-Systems-E-Records-E-Signatures-in-Clinical Investigations

October 2024

• Predictions for the Life Sciences 2024: Regulatory Science

2024

• Conducting Clinical Trials With Decentralized Elements

September 2024

• Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties

September 2024

• The FDA Language Access Plan 2024

August 12, 2024

• FDA Clinical Trial Diversity

May 8, 2024

• Conducting Remote Regulatory Assessments Questions and Answers

February 2024

• Collection of Race & Ethnicity Data in Clinical Trials & Clinical Studies for FDA-Regulated Medical Products

January 2024

• Project Equity: Diversity Action Plans – Oncology

November 2023

• Navigating FDA’s Revised Guidance on SIUU Communications

October 2023

• A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers\

April 2023

• Food and Drug Omnibus Reform Act of 2022

January 21, 2023

• Diversity Plans to Improve Enrollment of Patients

April 2022