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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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

Lindus Staff
Author

The FDA’s Draft Guidance on Using Data from AI to Drive Regulatory Decisions

January 9, 2025
Meri Beckwith
Co-Founder

EDC in Clinical Trials: Revolutionizing Data Management and Efficiency

Explore how Electronic Data Capture (EDC) systems are transforming clinical trials by enhancing data management and boosting efficiency.

January 6, 2025

Latest Stories

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
Meri Beckwith
Co-Founder

Asthma CRO: Choosing the Right Partner for Your Research

Discover the key factors to consider when selecting a CRO for asthma studies.

October 10, 2024
Lindus Staff
Author

A Recap of the FDA’s Final Guidance for Decentralized Clinical Trials (DCTs)

This blog covers key takeaways from the FDA's final guidance on decentralized clinical trial execution.

October 4, 2024
Michael Young
Co-Founder

Understanding the Importance of Phase 4 Trials in Clinical Research

Explore the critical role of Phase 4 trials in clinical research, where post-marketing studies enhance drug safety and efficacy.

September 24, 2024
Meri Beckwith
Co-Founder

Understanding Clinical Trial Regulation: Key Insights and Best Practices

Dive into the intricate world of clinical trial regulation with our comprehensive guide.

September 24, 2024
Michael Young
Co-Founder

Effective Data Management in Clinical Research: Best Practices and Strategies

Discover essential best practices and innovative strategies for effective data management in clinical research.

September 24, 2024
Meri Beckwith
Co-Founder

Phase 1 vs Phase 2: Key Differences Explained

Discover the essential distinctions between Phase 1 and Phase 2 in our comprehensive guide.

September 24, 2024
Michael Young
Co-Founder

Phase 2a vs 2b: Key Differences in Clinical Trials Explained

Discover the essential distinctions between Phase 2a and 2b clinical trials in our comprehensive guide.

September 24, 2024
Michael Young
Co-Founder

Understanding IDE Clinical Trials: A Comprehensive Guide

Dive into our comprehensive guide on IDE clinical trials, where we unravel the complexities of Investigational Device Exemptions.

September 24, 2024
Michael Young
Co-Founder

Top Benefits of Using CTMS Software for Clinical Trials

Discover how Clinical Trial Management System (CTMS) software revolutionizes clinical trials by enhancing efficiency, improving data accuracy, and streamlining collaboration.

September 24, 2024
Michael Young
Co-Founder

Effective Strategies for Recruitment for Clinical Trials

Discover innovative and effective strategies for recruiting participants in clinical trials.

September 24, 2024
Michael Young
Co-Founder

How to Perfect Your IDE Submission: A Step-by-Step Guide

Unlock the secrets to a flawless IDE submission with our comprehensive step-by-step guide.

September 24, 2024
Meri Beckwith
Co-Founder

Effective Strategies for Clinical Research Patient Recruitment

Discover innovative and effective strategies for enhancing patient recruitment in clinical research.

September 24, 2024
Meri Beckwith
Co-Founder

Effective Strategies for Patient Recruitment for Clinical Trials

Discover innovative and proven strategies to enhance patient recruitment for clinical trials in this comprehensive article.

September 24, 2024
Meri Beckwith
Co-Founder

How EDC (Electronic Data Capture) Transforms Clinical Trials

Discover how Electronic Data Capture (EDC) is revolutionizing clinical trials by streamlining data collection, enhancing accuracy, and accelerating research timelines.

September 24, 2024
Michael Young
Co-Founder

Understanding Clinical Data Management: Meaning and Importance

Explore the essential world of clinical data management in our comprehensive article.

September 11, 2024
Meri Beckwith
Co-Founder

Effective Strategies for Clinical Trial Management

Discover essential strategies for optimizing clinical trial management in our latest article.

September 11, 2024
Michael Young
Co-Founder

Phases of Drug Development: A Comprehensive Guide

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

September 11, 2024

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General

Effective Clinical Trial Recruitment Strategies: Boost Participation and Success

January 10, 2025
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Understanding the Key Drug Development Stages: A Comprehensive Guide

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

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Understanding Database Lock in Clinical Trials: A Comprehensive Guide

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Understanding Clinical Trial Statistics: A Comprehensive Guide

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GCP in Clinical Trials: Ensuring Compliance and Quality in Research

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Understanding Clinical Phase 4: Post-Market Surveillance and Its Importance

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Understanding CTMS Meaning: A Comprehensive Guide

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

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