Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
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FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
FDA Watch: BD Receives FDA Approval for Veritor, a Pandemic Staple
The assay was widely used during the early months of COVID-19 and was a significant source of revenue growth for a time
FDA Watch: Agency Launches Database of Complete Response Letters Sent to Drug Manufacturers About Initial Rejections
The early focus is on drug applications, but it could spread to the laboratory test approval process as well
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
MeMed Sepsis Test Gains Breakthrough Device Designation
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
Which Recent FDA Webinars Are Most Useful for the LDT Rule?
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
