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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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
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Michael Young
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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
Meri Beckwith
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Discover the key factors in selecting the best Electronic Data Capture (EDC) systems for clinical trials.

January 6, 2025

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Michael Young
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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
Lindus Staff
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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.

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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

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
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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
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What Is Good Clinical Practice in Research?

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

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
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Co-Founder

Phase IIa Trials: Key Insights and Implications in Clinical Trials

Delve into the intricacies of Phase IIa clinical trials with our comprehensive guide, exploring their pivotal role in drug development, key insights, and the broader implications for medical research and patient care..

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Michael Young
Co-Founder

What Is a CTMS?

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

January 6, 2025
Michael Young
Co-Founder

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

Explore the key distinctions between Phase 1 and Phase 2 clinical trials in this insightful article.

January 6, 2025
Meri Beckwith
Co-Founder

What is an IDE Trial?

Explore the transformative effects and far-reaching implications of the IDE Trial in this insightful article.

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Meri Beckwith
Co-Founder

Pivotal Clinical Trials and Drug Approval

Explore how a groundbreaking clinical trial can shape the future of drug approval processes, influence regulatory decisions, and redefine treatment standards in the pharmaceutical industry..

January 6, 2025
Michael Young
Co-Founder

Understanding the Key Drug Development Stages: A Comprehensive Guide

Explore the intricate journey of drug development with our comprehensive guide, detailing each critical stage from discovery to market approval.

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Michael Young
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Effective Strategies for Clinical Research Recruitment Success

Discover proven strategies to enhance participant recruitment in clinical research.

January 6, 2025
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

Optimizing Clinical Trial Data Management: Best Practices and Tools

Discover the essential best practices and cutting-edge tools for optimizing clinical trial data management.

November 30, 2024
Meri Beckwith
Co-Founder

How Long Does a Clinical Trial Take? Understanding the Timeline

Discover the intricate timeline of clinical trials, from initial research to final approval.

January 6, 2025
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Defining Clinical Research: An Essential Guide

Explore the intricate world of clinical research with our essential guide.

November 30, 2024

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