Day: June 10, 2021

This week FDA approved Biogen’s new drug for Alzheimer’s disease, Aduhelm, despite getting a no-approval recommendation from its Advisory Committee. FDA has been strongly criticized in the media for this decision, but this is not the first time FDA made such decision and certainly not the last. There are several reasons why if FDA had … Read more

FDA’s self-imposed deadline to remove “enforcement discretion” on stem cell clinics ended last week, with prompt release of consumer announcement and blogs by FDA’s top regulators. However, the exact nature of the removal of enforcement discretion was not made clear. During the enforcement discretion period over the last 3-4 years, FDA issued 400 letters to … Read more