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:

(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... locations throughout Arkansas that offers insurance and financial preparation services, is providing an ... Rock City Rescue organization. , Rock City Rescue is a locally recognized nonprofit ...
(Date:10/13/2017)... IL (PRWEB) , ... October 13, 2017 , ... ... which established the certification process to promote standards of excellence for the field ... Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at the ...
(Date:10/13/2017)... ... ... Apple Rehab Shelton Lakes , which specializes in the delivery of ... part of a disaster drill on October 3rd. , Apple Rehab participated with the ... as well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). The ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a missionary ... Journey: From the Mountains to the Mission Field” is the creation of published author, ... ages and currently teaches a class of ladies at her church, which she has ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... , Oct. 2, 2017 The Rebound mobile app ... struggle to reverse the tide of prescription drug addiction. The ... their medicine intake and stepping down their dosage in a ... launch in December 2017; the first 100,000 people to sign ... at ...
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. ... big data solutions, today announced that its MyDario product is expected to ... TV listings for when The Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, ... ...
(Date:9/22/2017)... Md. , Sept. 22, 2017  As the ... Republican Senators Bill Cassidy (R-LA) and ... Information notes that the medical device industry is in ... medical device tax, the 2.3% excise tax on medical ... But they also want covered patients, increased visits and ...
Breaking Medicine Technology: