The FDA’s Draft Guidance on Using Data from AI to Drive Regulatory Decisions

2

mins read

January 9, 2025

Your library for CRO & clinical trials

Learn more about Lindus Health from our blog page. Our posts cover an array of topics from clinical developments to diversity.

General

The FDA’s Draft Guidance on Using Data from AI to Drive Regulatory Decisions

Lindus Staff
Author

In the spotlight

Lindus Staff
Author
Digital Therapeutics

The Vital Role of Clinical Trials and Independent Accreditation in Validating AI-Powered SaMDs

The integration of AI into healthcare is and will dramatically change the industry landscape. In order to ensure safety and efficacy in improving health outcomes, we must ensure the SaMDs being developed are both clinically validated and meet notified body requirements.

September 9, 2024
3
Mins
Lindus Staff
Author
General

Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.

July 10, 2024
5
Mins
Michael Young
Co-Founder
CNS

The Transformative Potential of Digital Mental Health

Discover how digital mental health tools are revolutionizing the way we approach mental well-being.

February 17, 2024
3
Mins

Latest stories

Meri Beckwith
Co-Founder

Top Features to Look for in a Clinical Data Management System

Discover the essential features that make a Clinical Data Management System effective and reliable.

January 6, 2025
Michael Young
Co-Founder

Effective Strategies for Clinical Research Recruitment Success

Discover proven strategies to enhance participant recruitment in clinical research.

January 6, 2025

Latest Stories

Michael Young
Co-Founder

Infectious Disease CRO Services: Enhancing Clinical Research Efficiency

Discover how Infectious Disease CRO services are revolutionizing clinical research by boosting efficiency and accelerating drug development.

October 10, 2024
Michael Young
Co-Founder

CROs in Ophthalmology: Revolutionizing Clinical Research in Eye Care

Discover how CRO ophthalmology is transforming clinical research in eye care, enhancing treatment outcomes, and accelerating innovation.

October 10, 2024
Lindus Staff
Author

Top Vaccine CROs: Leading Contract Research Organizations for 2025

Discover the top vaccine Contract Research Organizations (CROs) of 2024 that are at the forefront of innovation and excellence.

October 10, 2024
Meri Beckwith
Co-Founder

Vaccine CROs: Transforming Clinical Research and Development

Explore how Vaccine CROs are revolutionizing clinical research and development, accelerating vaccine innovation, and ensuring safety and efficacy in the fight against global health challenges.

October 10, 2024
Meri Beckwith
Co-Founder

Asthma CRO: Choosing the Right Partner for Your Research

Discover the key factors to consider when selecting a CRO for asthma studies.

October 10, 2024
Lindus Staff
Author

A Recap of the FDA’s Final Guidance for Decentralized Clinical Trials (DCTs)

This blog covers key takeaways from the FDA's final guidance on decentralized clinical trial execution.

October 4, 2024
Michael Young
Co-Founder

Understanding the Importance of Phase 4 Trials in Clinical Research

Explore the critical role of Phase 4 trials in clinical research, where post-marketing studies enhance drug safety and efficacy.

September 24, 2024
Meri Beckwith
Co-Founder

Understanding Clinical Trial Regulation: Key Insights and Best Practices

Dive into the intricate world of clinical trial regulation with our comprehensive guide.

September 24, 2024
Michael Young
Co-Founder

Effective Data Management in Clinical Research: Best Practices and Strategies

Discover essential best practices and innovative strategies for effective data management in clinical research.

September 24, 2024
Meri Beckwith
Co-Founder

Phase 1 vs Phase 2: Key Differences Explained

Discover the essential distinctions between Phase 1 and Phase 2 in our comprehensive guide.

September 24, 2024
Michael Young
Co-Founder

Phase 2a vs 2b: Key Differences in Clinical Trials Explained

Discover the essential distinctions between Phase 2a and 2b clinical trials in our comprehensive guide.

September 24, 2024
Michael Young
Co-Founder

Understanding IDE Clinical Trials: A Comprehensive Guide

Dive into our comprehensive guide on IDE clinical trials, where we unravel the complexities of Investigational Device Exemptions.

September 24, 2024
Michael Young
Co-Founder

Top Benefits of Using CTMS Software for Clinical Trials

Discover how Clinical Trial Management System (CTMS) software revolutionizes clinical trials by enhancing efficiency, improving data accuracy, and streamlining collaboration.

September 24, 2024
Michael Young
Co-Founder

Effective Strategies for Recruitment for Clinical Trials

Discover innovative and effective strategies for recruiting participants in clinical trials.

September 24, 2024
Michael Young
Co-Founder

How to Perfect Your IDE Submission: A Step-by-Step Guide

Unlock the secrets to a flawless IDE submission with our comprehensive step-by-step guide.

September 24, 2024
Meri Beckwith
Co-Founder

Effective Strategies for Clinical Research Patient Recruitment

Discover innovative and effective strategies for enhancing patient recruitment in clinical research.

September 24, 2024
Meri Beckwith
Co-Founder

Effective Strategies for Patient Recruitment for Clinical Trials

Discover innovative and proven strategies to enhance patient recruitment for clinical trials in this comprehensive article.

September 24, 2024
Meri Beckwith
Co-Founder

How EDC (Electronic Data Capture) Transforms Clinical Trials

Discover how Electronic Data Capture (EDC) is revolutionizing clinical trials by streamlining data collection, enhancing accuracy, and accelerating research timelines.

September 24, 2024
Michael Young
Co-Founder

Understanding Clinical Data Management: Meaning and Importance

Explore the essential world of clinical data management in our comprehensive article.

September 11, 2024
Meri Beckwith
Co-Founder

Effective Strategies for Clinical Trial Management

Discover essential strategies for optimizing clinical trial management in our latest article.

September 11, 2024

Speak with an expert about your study.

Get your study done faster. Try the CRO that everyone is talking about.
BOOK A MEETING

Filter stories by therapeutic area

AllMetabolicRespiratory
Women's Health CNS Cardiovascular
DermatologyInfectious Disease
DTxMedical DeviceDiagnostics
Metabolic
CNS
Respiratory
Women's health
Medical Device
Cariovascular
Dermatology
Infectious Disease
Diagnostics
Digital Therapeutics
Scroll to bottom
Respiratory 

The Power of AI in Respiratory Clinical Trials

January 22, 2025
3
Mins
All
Respiratory 
General

What Is Clinical Development? An In-Depth Guide

January 22, 2025
3
Mins
All
General
General

Breakthrough Clinical Trial Results: What They Mean for Future Treatments

January 22, 2025
3
Mins
All
General
General

Defining Good Clinical Practice: Essential Guidelines and Standards

January 21, 2025
3
Mins
All
General
General

Optimizing EDC Clinical Trials: A Comprehensive Guide

January 21, 2025
3
Mins
All
General
General

Understanding Phase 2b: Key Insights and Implications

January 17, 2025
3
Mins
All
General
General

Understanding the Pharmaceutical Development Timeline: Key Stages and Processes

January 17, 2025
3
Mins
All
General
General

Optimizing Electronic Data Capture in Clinical Research: A Comprehensive Guide

January 16, 2025
3
Mins
All
General
General

Pharma Development: Innovations Shaping the Future of Medicine

January 16, 2025
3
Mins
All
General
General

Optimizing Healthcare: The Role of a Clinical Database

January 16, 2025
3
Mins
All
General
CNS

Optimizing CNS Research with Adaptive Trial Designs

January 15, 2025
3
Mins
All
CNS
Dermatology

DCT Solutions for Dermatology

January 15, 2025
3
Mins
All
Dermatology
General

Understanding CTMS in Clinical Research: A Comprehensive Guide

January 15, 2025
3
Mins
All
General
General

Optimizing Clinical Trials: A Comprehensive Guide to CTMS Clinical Trial Management

January 15, 2025
3
Mins
All
General
General

Electronic Data Capture in Clinical Trials: Enhancing Accuracy and Efficiency

January 15, 2025
3
Mins
All
General
General

Understanding GCP in Clinical Research: A Comprehensive Guide

January 14, 2025
3
Mins
All
General
General

Strategies to Optimize Clinical Trial Patient Enrollment

January 14, 2025
3
Mins
All
General
General

GCP in Clinical Studies: Ensuring Compliance and Quality in Research

January 14, 2025
3
Mins
All
General
General

Optimizing Clinical Data Management Services for Enhanced Research Outcomes

January 13, 2025
3
Mins
All
General
General

Understanding Parallel Group Design: A Comprehensive Guide

January 13, 2025
3
Mins
All
General
General

GCP Clinical Guidelines: Ensuring Compliance and Best Practices

January 13, 2025
3
Mins
All
General
General

Effective Clinical Trial Recruitment Strategies: Boost Participation and Success

January 10, 2025
3
Mins
All
General
General

Phase IV Study Importance and Impact on Drug Safety

January 10, 2025
3
Mins
All
General
General

The FDA’s Draft Guidance on Using Data from AI to Drive Regulatory Decisions

January 9, 2025
2
Mins
All
General
General

EDC in Clinical Trials: Revolutionizing Data Management and Efficiency

January 9, 2025
3
Mins
All
General
General

Optimizing Clinical Trial Site Management: Best Practices and Strategies

January 9, 2025
3
Mins
All
General
General

What Is a Pivotal Trial?

January 9, 2025
3
Mins
All
General
General

Real-Time Monitoring in Clinical Trials: Enhancing Accuracy and Efficiency

January 8, 2025
3
Mins
All
General
General

Enhancing Safety Monitoring in Clinical Trials: Best Practices and Innovations

January 8, 2025
3
Mins
All
General
General

Continuous Monitoring in Clinical Trials: Enhancing Safety and Efficacy

January 8, 2025
3
Mins
All
General
General

Top 5 CROs of 2025: Leading the Charge in Clinical Innovation

January 6, 2025
3
Mins
All
General
General

Optimizing Clinical Data Management: Best Practices and Strategies

January 6, 2025
3
Mins
All
General
General

Top Clinical Data Management Software Solutions for 2025

January 6, 2025
3
Mins
All
General
General

How Do You Get FDA Approval?

December 20, 2024
3
Mins
All
General
General

Database Lock in Clinical Trials: A Comprehensive Guide

December 20, 2024
3
Mins
All
General
General

Understanding Early Phase Clinical Trials: A Comprehensive Guide

December 19, 2024
3
Mins
All
General
General

What Is Good Clinical Practice in Research?

December 19, 2024
3
Mins
All
General
General

Top Electronic Data Capture Systems Examples for Streamlined Data Management

December 19, 2024
3
Mins
All
General
General

Phases of Pharmaceutical Development: A Comprehensive Guide

December 18, 2024
3
Mins
All
General
General

Choosing the Best EDC Systems for Clinical Trials

December 18, 2024
3
Mins
All
General
General

What Is a CTMS?

December 17, 2024
3
Mins
All
General
General

Phase IIa Trials: Key Insights and Implications in Clinical Trials

December 17, 2024
3
Mins
All
General
General

What is an IDE Trial?

December 16, 2024
3
Mins
All
General
General

What are the Differences Between Phase 1 and Phase 2 Clinical Trials?

December 16, 2024
3
Mins
All
General
General

Understanding the Key Drug Development Stages: A Comprehensive Guide

December 13, 2024
3
Mins
All
General
General

Pivotal Clinical Trials and Drug Approval

December 13, 2024
3
Mins
All
General
Diagnostics

Understanding the FDA’s Guidance on Unauthorized HIV Blood Self-Collection Kits

December 13, 2024
3
Mins
All
Diagnostics
General

Top Features to Look for in a Clinical Data Management System

December 12, 2024
3
Mins
All
General
General

Effective Strategies for Clinical Research Recruitment Success

December 12, 2024
3
Mins
All
General
General

How Long Does a Clinical Trial Take? Understanding the Timeline

December 11, 2024
3
Mins
All
General
General

Optimizing Clinical Trial Data Management: Best Practices and Tools

December 11, 2024
3
Mins
All
General
General

Phase IV Clinical Studies in Drug Development

December 10, 2024
3
Mins
All
General
General

Defining Clinical Research: An Essential Guide

December 10, 2024
3
Mins
All
General
General

Unlocking Innovation: The Future of Clinical Research Services

December 9, 2024
3
Mins
All
General
General

Exploring the Different Types of Clinical Research

December 9, 2024
3
Mins
All
General
General

The NDA (New Drug Application) Process: A Comprehensive Guide

December 9, 2024
3
Mins
All
General
General

Exploring the Different Types of Medical Research

December 6, 2024
3
Mins
All
General
General

Understanding Parallel Study Design: A Comprehensive Guide

December 5, 2024
3
Mins
All
General
General

Understanding GCP Regulations: A Comprehensive Guide

December 5, 2024
Mins
All
General
General

EDC Clinical Study: Revolutionizing Data Management in Clinical Trials

December 4, 2024
3
Mins
All
General
General

Understanding the Basics of a Parallel Group Study in Clinical Research

December 4, 2024
3
Mins
All
General
General

Understanding Clinical Studies: A Comprehensive Definition and Overview

December 4, 2024
3
Mins
All
General
General

Understanding Clinical Research: Meaning and Importance Explained

December 4, 2024
3
Mins
All
General
General

What are Phase 4 Clinical Trials?

December 4, 2024
3
Mins
All
General
General

Maximizing Efficiency: The Ultimate Guide to Electronic Data Collection

December 3, 2024
3
Mins
All
General
General

Effective Strategies for Clinical Trial Patient Recruitment

December 3, 2024
3
Mins
All
General
General

Understanding the Stages of Drug Development: A Comprehensive Guide

December 3, 2024
3
Mins
All
General
Medical Device

Effective Strategies for an IDE Study: A Comprehensive Guide

December 3, 2024
3
Mins
All
Medical Device
General

What is a Clinical Trial? Understanding the Basics and Importance

December 3, 2024
Mins
All
General
General

Comprehensive Guide to Navigating the EDC Database

December 2, 2024
3
Mins
All
General
General

Innovations in Pharmaceutical Development: Shaping the Future of Medicine

December 2, 2024
3
Mins
All
General
General

Advancements in Clinical Development: Transforming Healthcare Innovations

December 2, 2024
3
Mins
All
General
General

Clinical Trial Study Definition

December 2, 2024
3
Mins
All
General
General

What is Clinical Testing?

December 2, 2024
3
Mins
All
General
General

Optimizing Clinical Data Management Services for Enhanced Research Outcomes

November 27, 2024
3
Mins
All
General
General

Understanding GCP: A Comprehensive Guide to Good Clinical Practice

November 27, 2024
3
Mins
All
General
General

What is Clinical Data Management?

November 26, 2024
3
Mins
All
General
General

Effective Clinical Trial Recruitment Strategies: Boosting Participation and Success

November 26, 2024
3
Mins
All
General
Women's Health

Optimizing Patient Journeys in Women's Health Clinical Trials

November 26, 2024
3
Mins
All
Women's Health
General

Understanding Database Lock in Clinical Trials: A Comprehensive Guide

November 25, 2024
3
Mins
All
General
General

Understanding Clinical Trial Statistics: A Comprehensive Guide

November 25, 2024
3
Mins
All
General
General

GCP in Clinical Trials: Ensuring Compliance and Quality in Research

November 22, 2024
3
Mins
All
General
General

Understanding the Role of a Site Management Organization in Clinical Trials

November 22, 2024
3
Mins
All
General
General

The Role of EDC in Clinical Research: Enhancing Data Accuracy and Efficiency

November 21, 2024
3
Mins
All
General
General

Developing an Effective Regulatory Strategy for Business Success

November 21, 2024
3
Mins
All
General
General

Understanding Clinical Phase 4: Post-Market Surveillance and Its Importance

November 21, 2024
3
Mins
All
General
General

Understanding the Drug Development Timeline: Key Stages and Challenges

November 20, 2024
3
Mins
All
General
General

Understanding CTMS Meaning: A Comprehensive Guide

November 20, 2024
3
Mins
All
General
General

How to Get FDA Approval: A Step-by-Step Guide

November 20, 2024
4
Mins
All
General
General

Understanding the FDA and NDA: A Comprehensive Guide

November 19, 2024
5
Mins
All
General
General

Unlocking the Potential of EDC Data in Clinical Trials

November 19, 2024
3
Mins
All
General
General

Understanding the Benefits of Electronic Data Capture Systems

November 19, 2024
3
Mins
All
General
General

Understanding the Importance of Phase IV Clinical Trials in Drug Development

November 18, 2024
3
Mins
All
General
General

Top EDC Software Solutions for Streamlining Clinical Trials in 2025

November 18, 2024
3
Mins
All
General
General

What is an adaptive clinical trial?

November 15, 2024
3
Mins
All
General
General

Understanding the Pharmaceutical Drug Development Process: A Comprehensive Guide

November 15, 2024
3
Mins
All
General
General

Top Features to Look for in Clinical Trial Management Software (CTMS)

November 15, 2024
3
Mins
All
General
General

Understanding the Role of a Clinical Site in Medical Research

November 14, 2024
3
Mins
All
General
General

How Long Do Clinical Trials Take? A Comprehensive Guide

November 14, 2024
3
Mins
All
General
General

Understanding IDE Exemption: A Comprehensive Guide

November 13, 2024
3
Mins
All
General