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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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

Latest stories

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

Latest Stories

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
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
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

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

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
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
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 Med Device CROs to Watch in 2025: Leading Innovators and Services

Discover the top medical device CROs set to revolutionize the industry in 2025.

October 10, 2024
Michael Young
Co-Founder

Top Respiratory CROs to Watch in 2025

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

October 10, 2024
Meri Beckwith
Co-Founder

Top Benefits of Partnering with a Medical Device CRO

Discover the key advantages of collaborating with a Medical Device Contract Research Organization (CRO).

October 10, 2024
Meri Beckwith
Co-Founder

Top Dermatology CROs in 2025: Leading Companies in Clinical Research

Explore the forefront of dermatological innovation with our comprehensive guide to the top Contract Research Organizations (CROs) in 2025.

October 10, 2024
Meri Beckwith
Co-Founder

Top Ophthalmology CROs to Watch in 2025

Explore the leading ophthalmology CROs poised to make waves in 2025.

October 10, 2024
Meri Beckwith
Co-Founder

Top Medical Device CROs to Watch in 2025

Discover the leading medical device CROs poised to make a significant impact in 2025.

October 10, 2024
Michael Young
Co-Founder

Top Diabetes CROs to Watch in 2025

Discover the leading diabetes contract research organizations poised to make a significant impact in 2025.

October 10, 2024
Michael Young
Co-Founder

Top Asthma CROs to Watch in 2025

Discover the leading asthma contract research organizations set to make waves in 2025.

October 10, 2024
Michael Young
Co-Founder

Top Obesity CROs to Watch in 2025

Discover the leading obesity contract research organizations poised to make significant strides in 2025.

October 10, 2024
Lindus Staff
Author

Selecting an Infant Care CRO: Key Factors to Consider

Discover the essential factors to consider when choosing an Infant Care Contract Research Organization (CRO).

October 16, 2024
Lindus Staff
Author

Infant Care CROs: Essential Tips for Choosing the Right Partner

Discover essential tips for selecting the perfect clinical research organization (CRO) partner in infant care.

October 16, 2024
Michael Young
Co-Founder

Selecting a Diabetes CRO: Key Considerations for Success

Discover the essential factors to consider when choosing a Clinical Research Organization (CRO) for diabetes studies.

October 10, 2024
Michael Young
Co-Founder

Clinical Research Optimization with a Diabetes CRO

Explore the intricacies of Diabetes Clinical Research Optimization (CRO) with strategies designed to enhance study efficiency and outcomes.

October 10, 2024

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General

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

January 9, 2025
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Diagnostics

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

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Diagnostics
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Unlocking the Potential of EDC Data in Clinical Trials

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Understanding the Importance of Phase IV Clinical Trials in Drug Development

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Gynecology CRO Services: Enhancing Clinical Research Outcomes

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Understanding Clinical Study Definition

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Women's Health CRO Services: A Comprehensive Guide

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Enhancing Clinical Research Outcomes with a Gynecology CRO

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Advancements in Gynecology Research: Exploring the Latest Breakthroughs

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Exploring the Latest Advances in Gynecology Clinical Trials

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

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Infectious Disease

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

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Cardiovascular 
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Top Med Device CROs to Watch in 2025: Leading Innovators and Services

October 31, 2024
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Top Respiratory CROs to Watch in 2025

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Top Dermatology CROs in 2025: Leading Companies in Clinical Research

October 30, 2024
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Top Ophthalmology CROs to Watch in 2025

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Mins
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Ophthalmology
Medical Device

Top Medical Device CROs to Watch in 2025

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Medical Device
Metabolic 

Top Diabetes CROs to Watch in 2025

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Top Asthma CROs to Watch in 2025

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Top Obesity CROs to Watch in 2025

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Selecting an Infant Care CRO: Key Factors to Consider

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Infant Care CROs: Essential Tips for Choosing the Right Partner

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Metabolic 

Selecting a Diabetes CRO: Key Considerations for Success

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Metabolic