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:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle ... chronic pain and the benefits of holistic treatments, Serenity Recovery Center of ... Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda ... orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including ... accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. ... articles published in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. ...
(Date:6/24/2016)... ... , ... National recruitment firm Slone Partners is pleased to announce ... experience, as Vice President of North American Capital Sales at HTG Molecular . ... sales team in the commercialization of the HTG EdgeSeq system and associated reagents in ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 Research ... World Market for Companion Diagnostic Tests" report to their ... Market for Companion Diagnostics The World Market ... and personalized medicine diagnostics. Market analysis in the report includes ... Test Market (In Vitro Diagnostic Kits) by Region (N. America, ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced ... as its e-clinical software solution of choice.  This ... best possible value to their clients by offering ... The preferred relationship establishes nowEDC as the EDC ... for MedSource,s full-service clients.  "nowEDC has long been ...
(Date:6/23/2016)... 23, 2016 Roche (SIX: RO, ROG; OTCQX: ... its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated ... shock. With this clearance, Roche is the first IVD ... solution for sepsis risk assessment and management. ... and PCT levels in blood can aid clinicians in ...
Breaking Medicine Technology: