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

Unpacking the FDA's latest warning on unauthorized HIV blood self-collection kits.

3

mins read

December 12, 2024

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.

Diagnostics

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

Unpacking the FDA's latest warning on unauthorized HIV blood self-collection kits.

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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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

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

Explore how real-time monitoring is revolutionizing clinical trials by boosting accuracy and efficiency.

January 6, 2025
Michael Young
Co-Founder

Enhancing Safety Monitoring in Clinical Trials: Best Practices and Innovations

Explore the latest best practices and groundbreaking innovations in safety monitoring for clinical trials.

January 6, 2025

Latest Stories

Meri Beckwith
Co-Founder

Effective Clinical Trial Recruitment Strategies: Boost Participation and Success

Discover proven strategies to enhance clinical trial recruitment, ensuring higher participation rates and successful outcomes.

January 6, 2025
Michael Young
Co-Founder

Phase IV Study Importance and Impact on Drug Safety

Explore the critical role of Phase IV studies in ensuring drug safety post-approval.

January 6, 2025
Lindus Staff
Author

The FDA’s Draft Guidance on Using Data from AI to Drive Regulatory Decisions

January 9, 2025
Meri Beckwith
Co-Founder

EDC in Clinical Trials: Revolutionizing Data Management and Efficiency

Explore how Electronic Data Capture (EDC) systems are transforming clinical trials by enhancing data management and boosting efficiency.

January 6, 2025
Meri Beckwith
Co-Founder

Optimizing Clinical Trial Site Management: Best Practices and Strategies

Discover the essential best practices and innovative strategies for optimizing clinical trial site management.

January 6, 2025
Michael Young
Co-Founder

What Is a Pivotal Trial?

Discover the crucial role of pivotal trials in clinical research, exploring how these definitive studies influence drug approval and shape the future of medical treatments..

January 6, 2025
Meri Beckwith
Co-Founder

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

Explore how real-time monitoring is revolutionizing clinical trials by boosting accuracy and efficiency.

January 6, 2025
Michael Young
Co-Founder

Enhancing Safety Monitoring in Clinical Trials: Best Practices and Innovations

Explore the latest best practices and groundbreaking innovations in safety monitoring for clinical trials.

January 6, 2025
Michael Young
Co-Founder

Continuous Monitoring in Clinical Trials: Enhancing Safety and Efficacy

Explore how continuous monitoring is revolutionizing clinical trials by boosting safety and efficacy.

January 6, 2025
Lindus Staff
Author

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

Discover the top 5 CROs to watch for in 2025 and why they stand out.

January 6, 2025
Michael Young
Co-Founder

Optimizing Clinical Data Management: Best Practices and Strategies

Discover the essential best practices and innovative strategies for optimizing clinical data management.

January 6, 2025
Michael Young
Co-Founder

Top Clinical Data Management Software Solutions for 2025

Discover the leading clinical data management software solutions set to revolutionize healthcare in 2025.

January 6, 2025
Michael Young
Co-Founder

How Do You Get FDA Approval?

Unlock the secrets to obtaining FDA approval with this comprehensive step-by-step guide.

January 6, 2025
Meri Beckwith
Co-Founder

Database Lock in Clinical Trials: A Comprehensive Guide

Unlock the complexities of database lock in clinical trials with our comprehensive guide.

January 6, 2025
Michael Young
Co-Founder

Understanding Early Phase Clinical Trials: A Comprehensive Guide

Delve into the world of early phase clinical trials with this comprehensive guide, exploring their significance, processes, and impact on medical advancements.

January 6, 2025
Michael Young
Co-Founder

What Is Good Clinical Practice in Research?

Discover the essentials of Good Clinical Practice (GCP) in research with this comprehensive guide.

January 6, 2025
Meri Beckwith
Co-Founder

Top Electronic Data Capture Systems Examples for Streamlined Data Management

Discover the leading electronic data capture systems that are revolutionizing data management.

January 6, 2025
Michael Young
Co-Founder

Phases of Pharmaceutical Development: A Comprehensive Guide

Explore the intricate journey of drug creation in our comprehensive guide to the phases of pharmaceutical development.

January 6, 2025
Meri Beckwith
Co-Founder

Choosing the Best EDC Systems for Clinical Trials

Discover the key factors in selecting the best Electronic Data Capture (EDC) systems for clinical trials.

January 6, 2025
Michael Young
Co-Founder

What Is a CTMS?

Discover the essentials of Clinical Trial Management Systems (CTMS) in this comprehensive guide.

January 6, 2025

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

January 9, 2025
2
Mins
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EDC in Clinical Trials: Revolutionizing Data Management and Efficiency

January 9, 2025
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Mins
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Optimizing Clinical Trial Site Management: Best Practices and Strategies

January 9, 2025
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January 9, 2025
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Real-Time Monitoring in Clinical Trials: Enhancing Accuracy and Efficiency

January 8, 2025
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Enhancing Safety Monitoring in Clinical Trials: Best Practices and Innovations

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Continuous Monitoring in Clinical Trials: Enhancing Safety and Efficacy

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How Do You Get FDA Approval?

December 20, 2024
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Database Lock in Clinical Trials: A Comprehensive Guide

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Understanding Early Phase Clinical Trials: A Comprehensive Guide

December 19, 2024
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General

What Is Good Clinical Practice in Research?

December 19, 2024
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General

Top Electronic Data Capture Systems Examples for Streamlined Data Management

December 19, 2024
3
Mins
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General
General

Phases of Pharmaceutical Development: A Comprehensive Guide

December 18, 2024
3
Mins
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Choosing the Best EDC Systems for Clinical Trials

December 18, 2024
3
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What Is a CTMS?

December 17, 2024
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Phase IIa Trials: Key Insights and Implications in Clinical Trials

December 17, 2024
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What is an IDE Trial?

December 16, 2024
3
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What are the Differences Between Phase 1 and Phase 2 Clinical Trials?

December 16, 2024
3
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Understanding the Key Drug Development Stages: A Comprehensive Guide

December 13, 2024
3
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General
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Pivotal Clinical Trials and Drug Approval

December 13, 2024
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General
Diagnostics

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

December 13, 2024
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Diagnostics
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Top Features to Look for in a Clinical Data Management System

December 12, 2024
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Effective Strategies for Clinical Research Recruitment Success

December 12, 2024
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December 11, 2024
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Phase IV Clinical Studies in Drug Development

December 10, 2024
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Defining Clinical Research: An Essential Guide

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Unlocking Innovation: The Future of Clinical Research Services

December 9, 2024
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Exploring the Different Types of Clinical Research

December 9, 2024
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The NDA (New Drug Application) Process: A Comprehensive Guide

December 9, 2024
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Exploring the Different Types of Medical Research

December 6, 2024
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Understanding Parallel Study Design: A Comprehensive Guide

December 5, 2024
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Understanding GCP Regulations: A Comprehensive Guide

December 5, 2024
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EDC Clinical Study: Revolutionizing Data Management in Clinical Trials

December 4, 2024
3
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Understanding the Basics of a Parallel Group Study in Clinical Research

December 4, 2024
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Understanding Clinical Studies: A Comprehensive Definition and Overview

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Understanding Clinical Research: Meaning and Importance Explained

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What are Phase 4 Clinical Trials?

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Maximizing Efficiency: The Ultimate Guide to Electronic Data Collection

December 3, 2024
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Effective Strategies for Clinical Trial Patient Recruitment

December 3, 2024
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Understanding the Stages of Drug Development: A Comprehensive Guide

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Effective Strategies for an IDE Study: A Comprehensive Guide

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Medical Device
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December 3, 2024
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Comprehensive Guide to Navigating the EDC Database

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Clinical Trial Study Definition

December 2, 2024
3
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What is Clinical Testing?

December 2, 2024
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Optimizing Clinical Data Management Services for Enhanced Research Outcomes

November 27, 2024
3
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Understanding GCP: A Comprehensive Guide to Good Clinical Practice

November 27, 2024
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What is Clinical Data Management?

November 26, 2024
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Effective Clinical Trial Recruitment Strategies: Boosting Participation and Success

November 26, 2024
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Optimizing Patient Journeys in Women's Health Clinical Trials

November 26, 2024
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Understanding Database Lock in Clinical Trials: A Comprehensive Guide

November 25, 2024
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Understanding Clinical Trial Statistics: A Comprehensive Guide

November 25, 2024
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GCP in Clinical Trials: Ensuring Compliance and Quality in Research

November 22, 2024
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Understanding the Role of a Site Management Organization in Clinical Trials

November 22, 2024
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The Role of EDC in Clinical Research: Enhancing Data Accuracy and Efficiency

November 21, 2024
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Developing an Effective Regulatory Strategy for Business Success

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

November 21, 2024
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Understanding the Drug Development Timeline: Key Stages and Challenges

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Understanding CTMS Meaning: A Comprehensive Guide

November 20, 2024
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How to Get FDA Approval: A Step-by-Step Guide

November 20, 2024
4
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Understanding the FDA and NDA: A Comprehensive Guide

November 19, 2024
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Unlocking the Potential of EDC Data in Clinical Trials

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Understanding the Benefits of Electronic Data Capture Systems

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Understanding the Importance of Phase IV Clinical Trials in Drug Development

November 18, 2024
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Top EDC Software Solutions for Streamlining Clinical Trials in 2025

November 18, 2024
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What is an adaptive clinical trial?

November 15, 2024
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Understanding the Pharmaceutical Drug Development Process: A Comprehensive Guide

November 15, 2024
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Top Features to Look for in Clinical Trial Management Software (CTMS)

November 15, 2024
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Understanding the Role of a Clinical Site in Medical Research

November 14, 2024
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How Long Do Clinical Trials Take? A Comprehensive Guide

November 14, 2024
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Understanding IDE Exemption: A Comprehensive Guide

November 13, 2024
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Understanding Drug Development Phases: A Comprehensive Guide

November 13, 2024
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Understanding the New Drug Application Process: A Comprehensive Guide

November 6, 2024
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Women's Health

Gynecology CRO Services: Enhancing Clinical Research Outcomes

November 6, 2024
3
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Understanding Clinical Study Definition

November 6, 2024
3
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Women's Health CRO Services: A Comprehensive Guide

November 5, 2024
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Understanding the Impact of a Pivotal Study in Clinical Research

November 5, 2024
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Enhancing Clinical Research Outcomes with a Gynecology CRO

November 5, 2024
3
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Women's Health
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Advancements in Gynecology Research: Exploring the Latest Breakthroughs

November 4, 2024
3
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Exploring the Latest Advances in Gynecology Clinical Trials

November 4, 2024
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Revolutionizing Clinical Research for Female Health and Wellness with a Women's Health CRO

November 4, 2024
3
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Top Infectious Disease CROs to Watch in 2025

November 1, 2024
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Infectious Disease
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Top Cardiovascular CROs 2025: Leading Clinical Research Organizations

November 1, 2024
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Cardiovascular 
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October 31, 2024
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Top Respiratory CROs to Watch in 2025

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October 31, 2024
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October 30, 2024
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Top Ophthalmology CROs to Watch in 2025

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Top Medical Device CROs to Watch in 2025

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Top Diabetes CROs to Watch in 2025

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Top Asthma CROs to Watch in 2025

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Metabolic