Day: April 4, 2019

This week FDA reiterated its goal to enforce strict regulation of all stem cells treatment. In the strongly worded blog, FDA emphasized that autologous stem cell treatments are also regulated under the regulations for INDs and BLA and that it is false to claim that FDA jurisdiction over such treatments is not applicable. FDA also … Read more

A joint blog by the FDA Commissioner and the Center Directors for Drug and Biologics this week highlighted the important role expanded access (also known as Compassionate INDs) plays in the treatment of patients with no available options, and the benefits it may provide the manufacturers. Besides being potentially helpful to needy patients, FDA noted … Read more