Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
In August, the U.S. Food and Drug Administration (FDA) issued a stern warning letter to a California-based company for manufacturing and distributing unapproved products derived from umbilical cord blood and for failure to...more
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
FDA historically has limited its enforcement actions against stem cell clinics to warning letters. On May 9, 2018, FDA went a step further and filed two complaints in federal court seeking permanent injunctions that would...more
On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more