JD Supra

Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

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issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...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

FDA finds data integrity problems in recent warning letters

The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...
JD Supra

Addressing Data Integrity Challenges in Medical Device Submissions

Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
Forbes

The Importance Of Data Integrity When Developing AI-Driven Apps

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. GenAI is also making a splash in software development and mobile applications. In fact, due ...
Forbes

The Battle For Data Integrity: Why Trust Is The Current Frontier In AI

Artificial intelligence is no longer an emerging technology—it is an embedded reality shaping the way we live, govern and do business. From predictive healthcare to autonomous defense systems, AI is ...