Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Judge Orders Florida Stem Cell Clinic To Stop Producing Stem Cell Treatments

Executive Summary

Federal court rules that US Stem Cell in Florida must halt injections of stem cell products until the company obtains licenses from the US FDA to market them and demonstrates compliance with drug GMP requirements. This action follows numerous adverse events associated with these product; several patients experienced vision loss after eye injections.

You may also be interested in...



US FDA’s Stem Cell Clinic Enforcement Takes A Hit With Loss In California Case

Federal judge denies government’s request to permanently enjoin California stem cell clinic from administering unapproved stromal vascular stem cell treatments, concluding they are not ‘drugs’ under the FD&CA. The ruling runs counter to a decision in a similar case involving a Florida stem cell clinic.

US FDA’s Stem Cell Clinic Enforcement Takes A Hit With Loss In California Case

Federal judge denies government’s request to permanently enjoin California stem cell clinic from administering unapproved stromal vascular stem cell treatments, concluding they are not ‘drugs’ under the FD&CA. Ruling runs counter to decision in similar case involving a Florida stem cell clinic.

US FDA Action On Regenerative Medicine May Be Hindered If Court Sides With Stem Cell Clinics

Pew Charitable Trusts calls for FDA to take more aggressive enforcement against regenerative medicine products, but the outcome of a bench trial involving two stem cell clinics may limit what the agency can do.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS125537

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel