FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Articles and Reports
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Keys to a Successful OSHA Annual Review of Your Lab’s Health & Safety Plan
A solid health and safety plan in the lab not only meets regulatory requirements, but also fosters a secure environment for staff
OSHA Guidance for Labs: 2024 and Beyond
Safety and health guidance for labs—including recent updates, forthcoming changes, and how lab professionals can stay up to date
Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Labs in Court: Two EKRA-Related Cases and Some Usual Suspects
Recent enforcement actions involved usual targets such as COVID-19, genetic, and urine drug testing, but EKRA also made an appearance
How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
