PATIENT SAFETY

The Efficiency of Machine Learning in Organizing Patient Safety Event Reports Patient safety is a critical aspect of healthcare, and...

In recent news, the medical community has been shaken by the shocking case of a physician assistant (PA) receiving a...

EMA’s CHMP Declines Renewal of Translarna and Rejects Nezglyal and Syfovre as New Medicines The European Medicines Agency’s (EMA) Committee...

Understanding IDMP: How Standardizing Global Medicinal Product Documentation Improves Patient Safety and Regulatory Efficiency in the Pharmaceutical Industry In the...

Understanding and Implementing Cybersecurity Threat Models to Meet FDA Requirements In today’s digital age, cybersecurity has become a critical concern...

The European Commission has recently introduced new extensions for In Vitro Diagnostic Devices (IVDs) and the European Database on Medical...

The Food and Drug Administration (FDA) has recently mandated additional cancer warnings for Chimeric Antigen Receptor T-cell (CAR-T) therapies. This...

Understanding Change Management in Computerized Systems for BioPharma Services In the rapidly evolving field of BioPharma services, computerized systems play...

Lilly Plant Blamed for Manufacturing Issues, According to Investigators In recent news, investigators have identified a Lilly plant as the...

Regenerative medicine is a rapidly evolving field that holds great promise for the treatment of various diseases and injuries. This...

Title: FDA Warnings, Bryan Johnson’s NYT Feature, and MUSE Cell Trial: Key Developments in the Biotech Industry Introduction: The biotech...

Understanding the Regulatory Aspects of Blood Bag Manufacturing: Insights from Operon Strategist Blood bags play a crucial role in the...

Identifying Key Risk Indicators and Enhancing Site Performance in Clinical Trials Clinical trials play a crucial role in the development...

Kimera Labs, a leading biotechnology company specializing in regenerative medicine, has recently made headlines by highlighting the fact that exosome...

A Guide to Clinical Investigation Timelines: MDCG Guidance Clinical investigations play a crucial role in the development and evaluation of...