Day: January 19, 2023

The FDA recently released an updated clinical protocol template designed for electronic documentation practices. This update provides additional instructions and suggestions for the various elements of clinical protocols to harmonize information needed for electronic information exchanges such as clinical trial registries. The template can be used for all stages of clinical trials for drugs, biologics, … Read more

The Federal Trade Commission (FTC) recently updated its guidance for advertisements for dietary supplements to define several terms commonly used for such products and specify compliance expectations for the supporting information for health claims. The guidance formalizes about 25 years of FTC enforcement actions based on these expectations and is a must-read for dietary supplement … Read more