Newsletter | March 26, 2024

03.26.24 -- Notable Public Comments On The FDA's Proposed Regulation For Laboratory Developed Tests


Notable Public Comments On The FDA’s Proposed Regulation For Laboratory Developed Tests

The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.

8 Key Takeaways Of The Proposed FDA Modernization Act 3.0

On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview. Note that the proposed legislation would still need to go through its course of passing the House and Senate and being signed by the president before becoming a law.


Revvity Introduces New Workflow To Accelerate Newborn Sequencing Research

Genseq Selects Sapio LIMS To Power Best-In-Class Next-Generation Sequencing Services

US BioTek Expands Diagnostic Testing Portfolio With Acquisition Of RealTime Laboratories

ACH First In U.S. To Implement Abbott's Advanced Laboratory Technology

QDx Pathology Services Adopts Proscia’s Software To Improve Speed And Precision

Optimal’s SciYbotic Range Of QA Equipment Represents Paradigm Shift In Tablet Testing

WPI Partners With TotalLab To Introduce 21 CFR Part 11 Into EVOM Product Line

Optimise The Global Medical Laboratory Workforce Through ASCP BOC Credentials

Babson Diagnostics To Launch Transformative Blood Testing Service With Retail Partners

Spectrum Solutions Releases The New SimplyPERIO Saliva Test Powered By SimplyTest

Precision Diagnostics Guide Biomarker-Targeted Therapies For Patients With Epithelial Ovarian Cancer