Day: October 18, 2018

A review of ten years of FDA database on dietary supplements tainted with drugs shows that supplements intended for sexual enhancement, weight loss and muscle building accounted for more than 95% of the tainted products. There are more than 100,000 dietary supplement products available in the US accounting for annual sales of more than $140 … Read more

Drug and biologics intended to treat rare diseases require better planning and due diligence due to unique challenges posed by smaller target populations. In a new guidance document released this week, FDA lists several common sense measures for sponsors prior to conducting the first-in-human studies with such products and suggests that these be discussed at … Read more