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Stem cells Food and Drug Administration (FDA) Warning Letters

McGuireWoods LLP

Lessons From FDA’s Warning Letter to Stem Cell Product Manufacturer

McGuireWoods LLP on

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

Holland & Knight LLP

FDA Issues Warning Letter Regarding Unapproved Stem Cell Products

Holland & Knight LLP on

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

AGG Food & Drug Newsletter - May 2018

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

Arnall Golden Gregory LLP

FDA Files Complaints in Federal Court Against Two Stem Cell Clinics

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

Hogan Lovells

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

Hogan Lovells on

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

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