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

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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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

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

Latest Stories

Meri Beckwith
Co-Founder

Understanding the Role of a Site Management Organization in Clinical Trials

Explore the pivotal role of Site Management Organizations (SMOs) in clinical trials, uncovering how they streamline processes, enhance efficiency, and ensure compliance, ultimately accelerating the path to medical breakthroughs.

November 22, 2024
Meri Beckwith
Co-Founder

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

Explore how Electronic Data Capture (EDC) systems are revolutionizing clinical research by boosting data accuracy and operational efficiency.

November 22, 2024
Michael Young
Co-Founder

Developing an Effective Regulatory Strategy for Business Success

Discover how to craft a robust regulatory strategy that drives business success.

November 22, 2024
Meri Beckwith
Co-Founder

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

Explore the critical role of Clinical Phase 4 in drug development, focusing on post-market surveillance.

November 22, 2024
Michael Young
Co-Founder

Understanding the Drug Development Timeline: Key Stages and Challenges

Explore the intricate journey of drug development, from initial discovery to market approval.

November 22, 2024
Meri Beckwith
Co-Founder

Understanding CTMS Meaning: A Comprehensive Guide

Delve into the world of Clinical Trial Management Systems (CTMS) with our comprehensive guide.

November 22, 2024
Michael Young
Co-Founder

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

Navigate the complex process of obtaining FDA approval with ease.

November 22, 2024
Michael Young
Co-Founder

Understanding the FDA and NDA: A Comprehensive Guide

Unlock the complexities of the FDA and NDA processes with this comprehensive guide.

November 22, 2024
Meri Beckwith
Co-Founder

Unlocking the Potential of EDC Data in Clinical Trials

Discover how Electronic Data Capture (EDC) systems are revolutionizing clinical trials by enhancing data accuracy, streamlining processes, and accelerating research outcomes.

November 22, 2024
Meri Beckwith
Co-Founder

Understanding the Benefits of Electronic Data Capture Systems

Explore the transformative advantages of Electronic Data Capture Systems in modern data management.

November 22, 2024
Michael Young
Co-Founder

Understanding the Importance of Phase IV Clinical Trials in Drug Development

Explore the critical role of Phase IV clinical trials in drug development, uncovering how they ensure long-term safety and effectiveness post-approval.

November 22, 2024
Michael Young
Co-Founder

Top EDC Software Solutions for Streamlining Clinical Trials in 2025

Discover the leading EDC software solutions revolutionizing clinical trials in 2025.

November 22, 2024
Michael Young
Co-Founder

What is an adaptive clinical trial?

Discover the innovative world of adaptive clinical trials, where flexibility and efficiency meet in medical research.

November 27, 2024
Meri Beckwith
Co-Founder

Understanding the Pharmaceutical Drug Development Process: A Comprehensive Guide

Explore the intricate journey of pharmaceutical drug development in this comprehensive guide.

November 22, 2024
Meri Beckwith
Co-Founder

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

Discover the essential features that make clinical trial management software effective and efficient.

November 22, 2024
Michael Young
Co-Founder

Understanding the Role of a Clinical Site in Medical Research

Explore the pivotal role clinical sites play in medical research, from facilitating groundbreaking studies to ensuring patient safety and data integrity.

November 22, 2024
Meri Beckwith
Co-Founder

How Long Do Clinical Trials Take? A Comprehensive Guide

Discover the intricate timeline of clinical trials with our comprehensive guide.

November 22, 2024
Michael Young
Co-Founder

Understanding IDE Exemption: A Comprehensive Guide

Explore the intricacies of IDE Exemption with our comprehensive guide, unraveling its significance in medical device research and development.

November 22, 2024
Meri Beckwith
Co-Founder

Understanding Drug Development Phases: A Comprehensive Guide

Unlock the complexities of drug development with our comprehensive guide.

November 22, 2024
Michael Young
Co-Founder

Understanding the New Drug Application Process: A Comprehensive Guide

Navigate the intricate journey of drug development with our comprehensive guide to the New Drug Application process.

October 31, 2024

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General

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