Day: April 17, 2025

Collecting data from both male and female volunteers is critical for appropriate evaluation of clinical trial outcomes. FDA’s latest guidance document outlines what the FDA expects when it comes to enrolling male and female participants, analyzing results by sex, and sharing this information in clinical study reports. Although this issue has been discussed extensively for … Read more

The FDA has announced the strengthening of a law signed in 2022 to reduce animal testing by creating a formal policy to require the use of AI models, lab-grown human tissues or organelles, and international safety data, if available, to replace traditional animal testing. The “shift” aims to “improve accuracy, reduce costs, and accelerate the … Read more