Tobacco Final Rule: Advice for Manufacturers

By Zachary Mietus On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including e-cigarettes, gels, and e-vapor among others. As... Read More

COA Compendium: A Closer Look at FDA’s Pilot Program

By Dr. Robert Roth As recently reported, FDA has held a public workshop entitled, “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.” For this initiative, FDA prepared a pilot document entitled “Clinical Outcome Assessment Compendium”, and has established a... Read More