Reply To: Labeling Test Articles for Preclinical studies
August 16, 2021 at 10:07 pmMy suggestion would be to create the same label you would for any clinical trial. If your trial is in the US the requirements (21CFR312.6) are minimal and can easily be met. You will never get push-back from an Agency by labeling to meet CT regulations. That would be the safest approach.
