A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...

Human data and samples are scientific gifts, and scientists must be stewards of them, ensuring that they are collected and ...

Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...

The USFDA further highlighted deficiencies in environmental monitoring in manufacturing areas, indicating gaps in ensuring controlled production conditions.

What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...