Medtech Insight 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.

Menu

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
My View
Tags:

In Brief: Neoprobe RIGScan CR49

This article was originally published in The Gray Sheet

  • News

Executive Summary

Neoprobe RIGScan CR49: Firm plans to submit additional clinical and manufacturing information requested by FDA as an amendment to its existing biologics license application "as soon as possible." Neoprobe submitted a BLA in December 1996 for the radioimmuno-guided surgery system for detection of metastatic colon cancer ("The Gray Sheet" July 21, I&W-5). The RIGScan CR49 system consists of I125 labeled Colorectal 49 monoclonal mouse antibody and the Neoprobe 1000 radiation detection probe. Neoprobe President David Bupp notes the firm intends "to meet with the FDA at our earliest opportunity to determine the scope of the information requests"...

Table

View full table

Tags:
Latest Headlines

Discreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple Watch

Shuren Says CDRH Is ‘Turning The Ship Around’ As Operations Return To Normal

EU: Good News For IVDs And For Future Transparency Of Medtech Compliance

Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease

See All
UsernamePublicRestriction

Register

MT009375

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

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