Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Views
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Delcath Systems Receives Refusal to File Letter From FDA

February 22, 2011 By Bio-Medicine.Org

NEW YORK, Feb. 22, 2011 /PRNewswire/ — Delcath Systems, Inc.
(Nasdaq:
DCTH
) announced today that the Company has received a “refusal
to file” letter from the U.S. Food & Drug Administration (FDA)
for the New Drug Application (NDA) for its proprietary
chemosaturation system used in the treatment of patients with
metastatic melanoma in the liver through the percutaneous
intra-arterial administration of melphalan hydrochloride.
 Delcath expects to submit a formal meeting request to the FDA
this week and intends to meet with the FDA at the earliest
opportunity to discuss the issues raised and to confirm our
understanding of the remedies required for the filing to be
accepted.  Based on management’s current understanding of the
information in the FDA’s letter, the Company intends to resubmit
the NDA by September 30, 2011.  

In accordance with application regulations, the FDA has the
ability to formally file or refuse to file an application within 60
days of the completion of the submission, which occurred on
December 22, 2010.  Neither the acceptance nor non-acceptance
of the NDA filing is a determination of the approvability of the
chemosaturation system.

“The FDA’s letter requested information involving manufacturing
plant inspection timing, product and sterilization validations and
additional safety information that we already planned on filing
with our 120 day safety update in April, as well as additional
statistical analysis clarification,” said Eamonn P. Hobbs, CEO
& President of Delcath Systems. “We believe that we will be
able to provide the requested information in an updated application
and we expect to resubmit the NDA by the end of the third quarter
of this year.  In the meantime, the CE Mark Technical File
review process for marketing approval of the Hepatic
ChemoSAT™ Delivery System continues on schedule.  Our
expec

‘/>”/>

SOURCE

Related Articles Read More >

An illustration of Embolization Inc.'s Nitinol Enhanced Device (NED).
This nitinol vascular embolization device has another shape memory material up its sleeve
A photo of nitinol, a nickel-titanium alloy used for medical devices such as stents, heart valves, catheters and orthopedics.
What is nitinol and where is it used?
July 2025 edition: The Surgical Robotics issue, featuring Capstan Medical, J&J and Zimmer Biomet
A photo of Capstan Medical's mitral valve implant, which uses nitinol.
Capstan Medical’s R&D head discusses the heart valve and robotics startup’s tech, engineering challenges and solutions, advice for others in medtech and how to join his team
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Views
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe