Navigation Links
Northfield Labs Receives FDA Comments

Northfield Laboratories, founded in 1985, is a leading developer of an oxygen-carrying blood substitute. Its product, PolyHeme, is the only blood substitute undergoing clinical trials that has been tested at large enough dosages to be considered a substitute for acute blood loss in trauma and surgical settings. As a result of the process used to manufacture the blood substitute, essentially a solution of polymerized hemoglobin, PolyHeme has a longer shelf life than blood, requires no cross matching and does not transmit disease. //

Northfield Laboratories Inc. reported that it received comments from the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) on its Biologics License Application (BLA), submitted August 2001. CBER indicated that they are seeking additional information before accepting the application for filing and issued a Refusal-to-File letter to the company.

" Refusals for first-time submissions are common,'' said Richard DeWoskin, chief executive officer of Northfield Laboratories Inc. " We are encouraged by the constructive information provided in CBER's initial response, and believe that while the next few months will be busy, there is good reason to expect that modifications resulting from this feedback will help us to progress to the next stage of the application process. The regulatory review will be a multi-stage process. There now will be a period of several weeks during which we will interact with CBER to clarify and come to fully understand the issues in question." said Richard.

The company said the letter included both questions and comments about Northfield's blood substitute, PolyHeme, from CBER. Management said it will quickly begin the process of addressing these issues.
'"/>




Page: 1

Related medicine news :

1. Fifth US Patient Receives Artificial Heart
2. British MPs Say Prostate Cancer Receives Low Priority in the NHS
3. Abbott Receives CE Mark Certification
4. Zactima Receives Fast Track Designation By The FDA
5. East London Receives World Class New Private Hospital Facility
6. Brinda Karat Receives Legal Notice over Ramdev Issue
7. Quake-Hit Pakistan Receives 30 Field Hospitals From Cuba
8. Medtronic’s Insulin Pump Receives Regulatory Approva
9. Aurobindo Receives Approval from USFDA for anti-AIDS drug
10. Sunscreen Blocking UVA Radiation Receives Federal Approval
11. Eddie Thompson Receives Advanced Cancer Treatment
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:9/20/2017)... ... September 20, 2017 , ... “The Financial Favor of God; ... Favor of God; Second Edition” is the creation of published author, Brooks Rathell. , ... opportunity to talk to you about the financial favor of God. Not only does ...
(Date:9/20/2017)... ... ... “Monique”: is the story of Monique, whose mother’s deteriorating physical condition forces the ... has owned four beauty salons and written a book regarding the author’s success in ... , “The doctor’s office was only three blocks away, and she could walk it, ...
(Date:9/19/2017)... ... September 19, 2017 , ... Only a few physicians were selected to receive ... Ross A. Clevens, MD, FACS . The founder and medical director of Clevens ... who trained at Yale, Harvard and the University of Michigan. He has served patients ...
(Date:9/19/2017)... ... September 19, 2017 , ... PAPA Healthcare, Inc. announced ... called, “PAPA Healthcare helps fill gaps, provide essential insights, and improve productivity.” ... operations by leveraging PAPA Healthcare’s post-acute productivity and analytics solutions. , St. Vincent’s ...
(Date:9/19/2017)... ... September 19, 2017 , ... Peter Chandonait, ... President’s Malaria Initiative (PMI) Africa Indoor Residual Spraying (AIRS) Project , has ... , The Innovation to Action Award, a USAID Catalyst Award, recognizes USAID staff ...
Breaking Medicine News(10 mins):
(Date:9/6/2017)... -- Eli Lilly and Company (NYSE: LLY ... galcanezumab and lasmiditan, two investigational treatments for migraine, at ... taking place Sept. 7-10 in Vancouver ... data from an open-label study evaluating the safety and ... 240 mg) for the prevention of migraine. Galcanezumab is ...
(Date:9/5/2017)... N.J. , Sept. 5, 2017  Getinge, ... has created a vibrant charitable donation program -- ... and support congenital heart defect research by The ... providers and the general public are encouraged to ... and submit the completed artwork to the gallery ...
(Date:9/1/2017)... Michael Penna , President and CEO ... for growth in his response to the July 13, ... seeking a buyer for eMDs. Penna,s company, Complete HealthCare ... Value Added Reseller and national leader in the independent ... "As the healthcare market continues to dictate consolidation, healthcare ...
Breaking Medicine Technology: