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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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

Meri Beckwith
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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
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What Is a CTMS?

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

January 6, 2025

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Understanding the Stages of Drug Development: A Comprehensive Guide

Explore the intricate journey of drug development with our comprehensive guide.

November 30, 2024
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Effective Strategies for an IDE Study: A Comprehensive Guide

Discover proven strategies for conducting an Investigational Device Exemption (IDE) study with our comprehensive guide.

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What is a Clinical Trial? Understanding the Basics and Importance

Discover the fundamentals of clinical trials, their significance in medical research, and how they contribute to advancements in healthcare.

November 30, 2024
Michael Young
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Comprehensive Guide to Navigating the EDC Database

Unlock the full potential of the EDC Database with our comprehensive guide.

December 11, 2024
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Innovations in Pharmaceutical Development: Shaping the Future of Medicine

Explore the groundbreaking innovations in pharmaceutical development that are revolutionizing the future of medicine.

November 30, 2024
Michael Young
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Advancements in Clinical Development: Transforming Healthcare Innovations

Explore the latest breakthroughs in clinical development that are revolutionizing healthcare.

November 30, 2024
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Clinical Trial Study Definition

Delve into the world of clinical trials with our comprehensive guide, unraveling the definitions, phases, and significance of these pivotal studies in advancing medical science and ensuring patient safety..

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Michael Young
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What is Clinical Testing?

Discover the ins and outs of clinical testing with our comprehensive guide.

November 30, 2024
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Optimizing Clinical Data Management Services for Enhanced Research Outcomes

Discover how optimizing clinical data management services can lead to improved research outcomes.

November 28, 2024
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Co-Founder

Understanding GCP: A Comprehensive Guide to Good Clinical Practice

Explore the essentials of Good Clinical Practice (GCP) with our comprehensive guide.

November 22, 2024
Meri Beckwith
Co-Founder

What is Clinical Data Management?

Discover the fundamentals of Clinical Data Management in this essential guide.

November 28, 2024
Michael Young
Co-Founder

Effective Clinical Trial Recruitment Strategies: Boosting Participation and Success

Discover innovative clinical trial recruitment strategies that enhance participation and drive success.

November 28, 2024
Lindus Staff
Author

Optimizing Patient Journeys in Women's Health Clinical Trials

Explore innovative strategies for enhancing patient experiences in women's health clinical trials.

November 27, 2024
Michael Young
Co-Founder

Understanding Database Lock in Clinical Trials: A Comprehensive Guide

Explore the critical process of database lock in clinical trials with our comprehensive guide.

November 28, 2024
Meri Beckwith
Co-Founder

Understanding Clinical Trial Statistics: A Comprehensive Guide

Unlock the complexities of clinical trial statistics with our comprehensive guide.

November 28, 2024
Michael Young
Co-Founder

GCP in Clinical Trials: Ensuring Compliance and Quality in Research

Explore how Good Clinical Practice (GCP) guidelines shape the landscape of clinical trials, ensuring compliance, enhancing quality, and safeguarding participant welfare.

November 22, 2024
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
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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

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