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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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

Michael Young
Co-Founder

Enhancing Safety Monitoring in Clinical Trials: Best Practices and Innovations

Explore the latest best practices and groundbreaking innovations in safety monitoring for clinical trials.

January 6, 2025
Michael Young
Co-Founder

Continuous Monitoring in Clinical Trials: Enhancing Safety and Efficacy

Explore how continuous monitoring is revolutionizing clinical trials by boosting safety and efficacy.

January 6, 2025

Latest Stories

Michael Young
Co-Founder

Choosing the Right Ophthalmology CRO

Discover how to select the ideal ophthalmology CRO for your clinical trials.

October 10, 2024
Michael Young
Co-Founder

Choosing the Right Dermatology CRO

Discover how to select the ideal dermatology CRO for your clinical trials.

October 10, 2024
Meri Beckwith
Co-Founder

Key Benefits and Considerations of Utilizing an Infectious Disease CRO

Explore the pivotal role of Infectious Disease Contract Research Organizations (CROs) in advancing medical research.

October 10, 2024
Michael Young
Co-Founder

Optimizing Cardiovascular CRO Strategies for Enhanced Clinical Trials

Discover innovative strategies to optimize cardiovascular clinical research organization (CRO) processes, enhancing trial efficiency and outcomes.

October 10, 2024
Michael Young
Co-Founder

Understanding CROs for Infectious Disease: Prevention and Treatment Strategies

Explore the complexities of Carbapenem-Resistant Organisms (CRO) in infectious diseases with our comprehensive guide.

October 10, 2024
Meri Beckwith
Co-Founder

Understanding CROs for Medical Devices: Key Insights and Innovations

Explore the transformative world of CRO medical devices with our in-depth article, uncovering essential insights and the latest innovations driving advancements in healthcare technology.

October 10, 2024
Michael Young
Co-Founder

CROs for Dermatology: Transforming Clinical Research in Skin Health

Explore how CRO dermatology is revolutionizing skin health research by streamlining clinical trials, enhancing patient outcomes, and accelerating the development of innovative dermatological treatments.

October 10, 2024
Michael Young
Co-Founder

Selecting an Obesity CRO: Key Factors to Consider

Discover the essential criteria for choosing the right Contract Research Organization (CRO) for obesity studies.

October 10, 2024
Michael Young
Co-Founder

Understanding Obesity CROs: Strategies for Effective Clinical Research

Explore the intricacies of obesity clinical research optimization (CRO) with our comprehensive guide.

October 10, 2024
Lindus Staff
Author

In-House or CRO – Which Way Do You Go?

This blog highlights elements to consider as you decide whether or not to run a clinical trial with a CRO or fully internally.

October 2, 2024
Meri Beckwith
Co-Founder

Selecting an Asthma CRO: Key Factors to Consider

Discover the essential criteria for choosing the right Contract Research Organization (CRO) for asthma studies.

October 10, 2024
Michael Young
Co-Founder

Top COPD CROs: Leading Contract Research Organizations for COPD Studies

Discover the top contract research organizations (CROs) specializing in COPD studies.

October 10, 2024
Michael Young
Co-Founder

Respiratory CROs: Key Benefits and Services Explained

Discover the essential benefits and comprehensive services offered by Respiratory Contract Research Organizations (CROs).

October 10, 2024
Michael Young
Co-Founder

Selecting a COPD CRO: Key Factors to Consider

Discover the essential factors to consider when selecting a Contract Research Organization (CRO) for COPD studies.

October 10, 2024
Meri Beckwith
Co-Founder

Understanding COPD CROs: Clinical Research Opportunities and Challenges

Explore the intricate landscape of COPD clinical research, delving into the opportunities and challenges that shape advancements in treatment.

October 10, 2024
Meri Beckwith
Co-Founder

Optimizing Vaccine CRO Selection: Key Factors to Consider

Discover the essential criteria for selecting the ideal Contract Research Organization (CRO) for vaccine development.

October 10, 2024
Michael Young
Co-Founder

Infectious Disease CRO Services: Enhancing Clinical Research Efficiency

Discover how Infectious Disease CRO services are revolutionizing clinical research by boosting efficiency and accelerating drug development.

October 10, 2024
Michael Young
Co-Founder

CROs in Ophthalmology: Revolutionizing Clinical Research in Eye Care

Discover how CRO ophthalmology is transforming clinical research in eye care, enhancing treatment outcomes, and accelerating innovation.

October 10, 2024
Lindus Staff
Author

Top Vaccine CROs: Leading Contract Research Organizations for 2025

Discover the top vaccine Contract Research Organizations (CROs) of 2024 that are at the forefront of innovation and excellence.

October 10, 2024
Meri Beckwith
Co-Founder

Vaccine CROs: Transforming Clinical Research and Development

Explore how Vaccine CROs are revolutionizing clinical research and development, accelerating vaccine innovation, and ensuring safety and efficacy in the fight against global health challenges.

October 10, 2024

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General

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

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

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

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Top Respiratory CROs to Watch in 2025

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Top Ophthalmology CROs to Watch in 2025

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Top Medical Device 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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Selecting a Diabetes CRO: Key Considerations for Success

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Metabolic