The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.

CES attendees saw health-tracking gadgets making bold promises: toothbrushes detecting diabetes, mirrors assessing 20-year ...

BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers teams to enhance validation precision ...

Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...

This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...

The SNS records neural activity from 60 channels across four brain regions—an order-of-magnitude increase over commercially ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

A genetic disorder that leads to bleeding episodes and life-threatening infections has a new FDA approved treatment, a regulatory decision that marks two notable firsts — the first gene therapy for ...

O. Rose Broderick reports on the health policies and technologies that govern people with disabilities’ lives. Before coming to STAT, she worked at WNYC’s Radiolab and Scientific American, and her ...

(RTTNews) - Integra LifeSciences (IART) announced that it has received U.S. FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System, for use in cardiac surgery. This clearance ...