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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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

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

January 6, 2025

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Michael Young
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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
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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
Meri Beckwith
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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
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
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

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 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

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 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 Clinical Study Definition

Unlock the complexities of clinical studies with our comprehensive guide.

October 31, 2024
Emma Ogburn
VP of Clinical Operations

Gynecology CRO Services: Enhancing Clinical Research Outcomes

Discover the leading gynecology CRO services that are revolutionizing clinical research outcomes.

October 31, 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
Emma Ogburn
VP of Clinical Operations

Enhancing Clinical Research Outcomes with a Gynecology CRO

Explore how Gynecology Contract Research Organizations (CROs) are revolutionizing clinical research outcomes.

October 29, 2024
Meri Beckwith
Co-Founder

Understanding the Impact of a Pivotal Study in Clinical Research

Explore the transformative effects of a groundbreaking study in clinical research.

October 31, 2024
Meri Beckwith
Co-Founder

Women's Health CRO Services: A Comprehensive Guide

Explore how Contract Research Organizations (CROs) are revolutionizing women's health by enhancing clinical research efficiency and innovation.

October 31, 2024
Emma Ogburn
VP of Clinical Operations

Revolutionizing Clinical Research for Female Health and Wellness with a Women's Health CRO

Discover how Women's Health CROs are transforming clinical research by focusing on female-specific health issues.

October 29, 2024
Michael Young
Co-Founder

Exploring the Latest Advances in Gynecology Clinical Trials

Delve into the cutting-edge innovations in gynecology clinical trials, uncovering breakthroughs that are shaping the future of women's health.

October 29, 2024
Emma Ogburn
VP of Clinical Operations

Advancements in Gynecology Research: Exploring the Latest Breakthroughs

Discover the cutting-edge breakthroughs in gynecology research that are transforming women's health.

October 29, 2024
Michael Young
Co-Founder

Top Cardiovascular CROs 2025: Leading Clinical Research Organizations

Discover the leading cardiovascular Contract Research Organizations (CROs) of 2025, driving innovation and excellence in clinical research.

October 10, 2024
Meri Beckwith
Co-Founder

Top Infectious Disease CROs to Watch in 2025

Discover the leading infectious disease Contract Research Organizations (CROs) poised to make significant impacts in 2025.

October 10, 2024

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