Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

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 ...

SUNNYVALE, Calif.--(BUSINESS WIRE)--DvSum, a leader in data intelligence management, is pleased to announce its partnership with Booz Allen Hamilton and the U.S. Food and Drug Administration (FDA) to ...

The main market opportunities lie in providing solutions for secure digital record management and compliance with FDA regulations. Companies can capitalize on the demand for effective Quality ...

Market opportunities arise from the growing need for modernization and compliance assurance in FDA-regulated industries focusing on data integrity. Emphasizing cloud computing, automation, and mobile ...

With regulatory agencies like the FDA, EMA, and MHRA intensifying data integrity compliance, significant market opportunities exist in providing robust data management solutions. Organizations can ...

MORRISVILLE, N.C., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its third FDA inspection, further ...

Some experts have blamed the issues on drastic staffing and budget cuts instituted by the Trump administration.

Allurion Technologies (ALUR) announced it has passed critical milestones in the FDA pre-market approval process for the Allurion Smart Capsule. In ...