Newsletter - October 18, 2018
FDA’s Guidance on Successful Development of Rare Disease Products
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...Read More
Certain Classes of Dietary Supplements Contain Drugs More Often Than Others
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...Read More
FDA’s Guidance on Successful Development of Rare Disease Products
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...Read More
Certain Classes of Dietary Supplements Contain Drugs More Often Than Others
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...Read More
