Newsletter - January 10, 2019
Living with the Shutdown: What’s Still On at FDA and What’s on Hold.
With the US government partial shutdown completing its 20th day, it is important for the regulated industry to understand that despite the event, many activities at the FDA continue as normal (as much as one can define “normal”). First, the things that don’t change. Pharmacovigilance activities continue as normal...Read More
FDA Starts to Turn the Screws on the Stem Cell Clinics
Just a few days before Christmas, FDA sent letters to several stem cell clinics asking them to respond to FDA’s finding that they are offering stem cell products that are not compliant with the law. The letters are gentle reminder that FDA is not going to ignore these clinics for long and that it depends on...Read More
Living with the Shutdown: What’s Still On at FDA and What’s on Hold.
With the US government partial shutdown completing its 20th day, it is important for the regulated industry to understand that despite the event, many activities at the FDA continue as normal (as much as one can define “normal”). First, the things that don’t change. Pharmacovigilance activities continue as normal...Read More
FDA Starts to Turn the Screws on the Stem Cell Clinics
Just a few days before Christmas, FDA sent letters to several stem cell clinics asking them to respond to FDA’s finding that they are offering stem cell products that are not compliant with the law. The letters are gentle reminder that FDA is not going to ignore these clinics for long and that it depends on...Read More
