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Decoding the FDA’s Latest Draft Guidance on Diversity in Clinical Trials

Learn more about the key takeaways from the FDA's latest draft guidance regarding diversity in clinical trials and what this means for future research.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

Michael Young
Co-Founder

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
Author

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.

January 6, 2025

Latest Stories

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
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

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

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
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
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

Effective Strategies for Clinical Research Patient Recruitment

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

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
Meri Beckwith
Co-Founder

Effective Strategies for Clinical Trial Recruitment

Discover innovative and proven strategies for enhancing clinical trial recruitment in our latest article.

September 11, 2024
Meri Beckwith
Co-Founder

Understanding Investigational Device Exemption: A Comprehensive Guide

Dive into our comprehensive guide on Investigational Device Exemption (IDE) to uncover the essential processes, regulations, and implications for medical device development.

September 11, 2024
Meri Beckwith
Co-Founder

Types of Clinical Studies: An In-Depth Guide

Explore the diverse landscape of clinical studies in our comprehensive guide.

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
Meri Beckwith
Co-Founder

Understanding GCP Guidelines: A Comprehensive Overview

Explore the essential principles of Good Clinical Practice (GCP) in our comprehensive overview.

September 11, 2024
Meri Beckwith
Co-Founder

The Ultimate Guide to CTMS in Clinical Trials

Discover everything you need to know about Clinical Trial Management Systems (CTMS) in our comprehensive guide.

September 11, 2024
Meri Beckwith
Co-Founder

Understanding Clinical Research: Definition and Key Concepts

Dive into the world of clinical research with our comprehensive guide! This article unpacks the definition of clinical research and explores essential concepts that drive medical advancements.

September 11, 2024
Michael Young
Co-Founder

Understanding the Different Types of Clinical Trials

Explore the diverse landscape of clinical trials in our comprehensive guide.

September 11, 2024
Michael Young
Co-Founder

What is an IRB?

Discover the crucial role of Institutional Review Boards (IRBs) in research ethics.

September 11, 2024
Michael Young
Co-Founder

What is an IRB in clinical trials?

Discover the essential role of Institutional Review Boards (IRBs) in clinical trials.

September 11, 2024
Lindus Staff
Author

Visionary Recruitment: Finding and Engaging Participants for Ophthalmology Trials

This blog offers a comprehensive overview of key strategies to enhance recruitment in ophthalmology clinical trials.

September 23, 2024

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General

Top Clinical Data Management Software Solutions for 2025

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

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Enhancing Clinical Research Outcomes with a Gynecology CRO

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

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Choosing the Right Ophthalmology CRO

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Choosing the Right Dermatology CRO

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