All "Clinical Trials" articles

21 CFR Part 11: A guide for clinical trial compliance

When conducting or managing any part of a clinical trial, from pre-study through close-out, compliance with 21 CFR Part 11 is always required. The ...

The FDA's approach to digital health technology (DHT) is changing. That's a big deal.

In December 2021, the FDA revealed its draft guidance on "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations".