Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more
Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist...more
FDA authority to crack down on illegally marketed stem cell treatments confirmed -
On 3 June a U.S. District Court in Florida issued a decisive blow against US Stem Cell Clinic LLC, granting the U.S. Food and Drug...more
FDA authority to crack down on illegally marketed stem cell treatments confirmed -
On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more
6/7/2019
/ Biologics ,
Food and Drug Administration (FDA) ,
Fraudulent Marketing ,
Health Care Providers ,
Health Clinics ,
Life Sciences ,
Pharmaceutical Industry ,
PHSA ,
Regulatory Oversight ,
Regulatory Standards ,
Stem cells
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more
5/14/2018
/ Commercial Marketing ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Injunctions ,
Life Sciences ,
Patient Safety ,
Pharmaceutical Industry ,
Regenerative Medicine ,
Regulatory Oversight ,
Regulatory Standards ,
Stem cells
Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more
On November 16, in the context of announcing a comprehensive regenerative medicine policy framework, FDA released a draft guidance document that describes the expedited programs available for the development and review of...more
Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...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
9/21/2017
/ CGMP ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Health Care Providers ,
Inspection Rights ,
Life Sciences ,
Medical License ,
Pharmaceutical Industry ,
Safety Standards ,
Stem cells ,
Warning Letters
On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the...more