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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Ron Shinkman
Ron Shinkman is a veteran journalist and editor, with more than 20 years of experience in the healthcare business realm. He served as Los Angeles bureau chief of Modern Healthcare, and also wrote for the Los Angeles and Orange County Business Journals.
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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
Clinical Diagnostics InsiderDiagnostic Testing and Emerging TechnologiesEmerging Tests-dtetRon Shinkman
Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously
The PCR-driven test provides results in about 20 minutes in non-laboratory settings
Deals-lirDx Pipeline-lirEssentialInside the Lab Industry-lirLab Industry AdvisorLaboratory Industry ReportRon Shinkman
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
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
Labcorp, Quest, and ARUP Develop Bird Flu Tests with CDC Help
The assays were developed with the CDC as part of recent trend of public-private partnerships to improve pandemic preparedness
Dx Deals: Could Health Coaching Be a New Opportunity for Labs?
Quest Diagnostics will find out as it launches a new health coaching business that relies on lab testing, via its Pack Health subsidiary
ProPhase Labs’ Resolution for 2025: Nail Down a ‘Liquidity Event’
The company has lost nearly $36 million since 2023, but its CEO is aggressively pursuing new revenue options
FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
Dx Deals: New Premerger Regulations Could Slow Down Pace of Transactions
The new rules, which were approved by the FTC in October and will go into effect in mid-January, aim to put a damper on consolidation
