Day: April 27, 2017

Clinical trial populations are not very diverse. Minority populations form a very small fraction of the trial populations, much below their proportion in the US population leading to concerns about the effectiveness of approved products in populations under-represented in clinical trials. Since 2014, FDA’s Action Plan to Enhance the Collection and Availability of Subgroup Data requires … Read more

This week FDA announced that it sent Warning Letters to 14 manufacturers of about 65 dietary supplements making claims to treat cancer. One wonders what triggered this event and why did it take this long as obviously these companies did not spring up overnight. FDA’s news release about this event painted a rather innocent picture; … Read more