We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Sharpless Puts Stem Cell Makers on Notice Following Judge’s Smackdown

Sharpless Puts Stem Cell Makers on Notice Following Judge’s Smackdown

RedWarningStamp.gif
July 3, 2019

Acting FDA Commissioner Ned Sharpless issued another warning to stem cell manufacturers following a judge’s permanent injunction against two Florida clinics, promising that the agency’s “aggressive oversight” will continue.

A U.S. district judge in the Southern District of Florida found that US Stem Cell Clinic of Weston and US Stem Cell of Sunrise adulterated and misbranded cellular products made from patients’ adipose tissue. The agency secured permanent injunctions barring the companies and their chief scientific officer Kristin Comella from making or distributing the products until they comply with the law.

“We know that there are clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products,” Sharpless said. “The FDA has consistently stated that this is not true, and the result of this case proves that.”

Sharpless warned stem cell companies that the agency intends to stay on their case — and said they aren’t coming into compliance fast enough.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Thermo Fisher Scientific Gets FDA Premarket Approval for Companion Diagnostic

  • MHRA Grants Conditional Authorization to Moderna’s Bivalent COVID-19 Booster Vaccine

  • Organogenesis Gets 510(k) Clearance to Expand PuraPly Portfolio

  • FDA Grants Priority Review to sNDA for Lynparza

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing