Day: December 5, 2019

A perspective in the Journal of American Medical Association (JAMA) presents the unique challenge faced by medical professionals regarding use of CBD products by their patients. CBD products tread a fine line between legal and illegal products. Without any specific disease claims, CBD containing products can be sold as cosmetics or supplements. On the other … Read more

Last week FDA released the final guidance document for adaptive trials for drugs and biologics and it contains mostly the same information as the previous guidance documents by the Agency on the topic with some small but critical recommendations. FDA expects the sponsors to include the statistical analysis plan, the Data Monitoring Committee (DMC) charter, … Read more