FDA Predetermined Change Control Plans May Aid LDT Modifications
Karin Hughes, PhD
A new PCCP draft guidance outlines what elements the agency expects in these plans
FDA
Syphilis Assay Is Now Available on VITROS 3600, 5600, and 7600 Systems in the US
QuidelOrtho
There’s been a 36 percent increase in cases of primary and secondary syphilis since 2021
Webinar Recap: LDT Compliance Requirements for FDA Final Rule
Christine P. Bump
Christine P. Bump shares key insights from the FDA’s August 22 webinar on LDTs compliance
Association for Molecular Pathology Challenges FDA in Lawsuit against Final Rule on Laboratory-Developed Test Regulation
Association for Molecular Pathology
Drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures
Thermo Fisher Scientific Announces Extended 510k Clearance of Freelite Assays for Evaluation of MGUS, a Precursor to Multiple Myeloma
Thermo Fisher Scientific
Alongside other laboratory tests, Freelite assays are used as part of a workflow for diagnosing and monitoring monoclonal gammopathies
FDA's Draft Guidances for Emergency Use LDTs Spark Mixed Reactions
Julie Ballard
Public comments to the FDA’s draft guidances proposing enforcement policies for LDTs with and without a 564 Declared Emergency reveal a mix of support and opposition
AACR, ASA, and FDA Outline Considerations for Overall Survival Analyses in Clinical Trials
American Association for Cancer Research
New article outlines best practices, novel statistical methods, and suggestions for improving benefit-risk assessments in clinical trials
Disruptions in Availability of BD BACTEC Blood Culture Media Bottles—Letter to Healthcare Providers
U.S. Food and Drug Administration
The US is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues
ADLM Supports Letter Asking How the FDA Plans to Abide by SCOTUS Decision Limiting Power of Federal Agencies
Octavia Peck Palmer, PhD
In a statement, ADLM president Octavia Peck Palmer strongly supports Rep. Cassidy’s letter to the FDA asking how the agency plans to change its current practices under the recent Supreme Court ruling
First Point-of-Care Hepatitis C Test Authorized by FDA
U.S. Food and Drug Administration
The RNA-based test enables single-visit testing for HCV in about an hour, streamlining access to treatment