From drug safety testing to AI-enabled medical devices, ethical and regulatory standards are the backbone of trustworthy science. Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and ...

Chapter 14: Current Good Manufacturing Practices and Quality System Design Chapter 15: Canadian Good Manufacturing Practices and Establishment Licensing Chapter 25: Components of a REMS: Communication ...

BUFFALO, N.Y. — University at Buffalo researcher Murali Ramanathan, PhD, has used artificial intelligence (AI) since its nascent days while exploring possible treatments for multiple sclerosis (MS) ...

Investigational Products (IP) present a distinctively high-risk environment for labeling. Unlike commercial pharmaceuticals, ...

Preclinical or nonclinical evaluation is an integral part of the development of any drug. The process of developing a new radiopharmaceutical includes rigorous testing before it can be cleared for use ...

Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug Administration ...

Medical laboratory professionals such as this pair at work at ARUP are in high demand. The U.S. Bureau of Labor Statistics estimated that nearly 26,000 more of these highly trained specialists will be ...