Newsletter - May 10, 2018
FDA Files its First Injunctions against More Than 100 Stem Cell Clinics
Yesterday FDA took an unprecedented action of filing complaints in Federal courts seeking permanent injunctions to stop two stem cell treatment groups from selling stem cell products, a decision that affects more than 100 clinics in almost 40 states. These two groups were in the news last August when they were raided by FDA inspectors...Read More
FDA Provides Additional Guidance for Digital Health Products
In continuation of its efforts to simplify and limit regulation of digital health products, specifically software application that can be used for health-related outcomes, FDA released two new documents this week. Its guidance document on multiple-function devices, namely devices that are used both for regulated..Read More
FDA Files its First Injunctions against More Than 100 Stem Cell Clinics
Yesterday FDA took an unprecedented action of filing complaints in Federal courts seeking permanent injunctions to stop two stem cell treatment groups from selling stem cell products, a decision that affects more than 100 clinics in almost 40 states. These two groups were in the news last August when they were raided by FDA inspectors...Read More
FDA Provides Additional Guidance for Digital Health Products
In continuation of its efforts to simplify and limit regulation of digital health products, specifically software application that can be used for health-related outcomes, FDA released two new documents this week. Its guidance document on multiple-function devices, namely devices that are used both for regulated..Read More
