Newsletter | March 12, 2024

03.12.24 -- FDA's CBER Issues Final Guidance For CAR T Cell Products


A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.

FDA’s CBER Issues Final Guidance For CAR T Cell Products

The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.


Neurocode Launches Groundbreaking pTau217 Blood Test For Alzheimer's Disease Diagnosis

Emeritusdx Receives Clinical Laboratory Permit From NY State Department Of Health

Cal-Tec Labs Inc. Acquired By Medical Technology Associates

Lab Community Concerned About Patient Access To Testing If FDA Regulates Lab Tests

QuidelOrtho Receives Health Canada Approval For Quidel Triage PLGF Test

MGI Tech & Eurofins Genomics To Elevate Precision Health With DNBSEQ-T20×2 Sequencer

Co-Dx & CoSara Receive Clearance From Indian Regulators For Influenza Multiplex PCR Test

Key Proteo Announces Laboratory Expansion Plans Including New CLIA-Certified Laboratory

Ibex & PathPresenter Partner To Accelerate Adoption Of AI-Powered Digital Pathology

Eisai Invests In C2N To Support Simplifying The Diagnosis Of Early Alzheimer's Disease

Sunbird Bio's APEX Diagnostic Test Accurately Differentiates Key Alzheimer’s Disease Biomarker In Blood