FDA Registration for Drug Manufacturing Enters a New Era
The FDA's proposed drug manufacturing modernisation rule could accelerate distributed manufacturing, digital quality systems, and pharma supply chain resilience.
Is AI Quietly Creating a GDPR Crisis in Clinical Research?
Generative AI is transforming clinical trials, but a failure to distinguish between pseudonymised and anonymised data is creating costly regulatory gaps.
Optimising Clinical Trial Data Collection for Better Decisions
Learn how optimised clinical trial data collection improves data quality, reduces protocol and patient burden, and supports smarter clinical development.
Why Biopharma Scientists Spend Up to 80% of Their Time on Data Cleanup
Scientists should be spending their time advancing research, not cleaning data. Lily Helfrich of Benchling explains why fragmented systems are slowing biopharma discovery, how AI can transform legacy antibody data and what it takes to build a data foundation for the next generation of biologics.
CDRH Rare Disease Impact Initiative Sets New FDA Focus
The CDRH Rare Disease Impact Initiative puts greater focus on rare disease devices, patient engagement, evidence strategy, and closer FDA coordination.
Can AI and Machine Learning in Sterile Manufacturing Improve Quality?
Discover how AI/ML in sterile pharmaceutical manufacturing enables predictive maintenance, quality control, contamination detection, and intelligent GMP operations.