Autism and vaccines: What's the link? Mar 22, 2008
He was speaking to DR. egan from cber of the FDA he said you had a interim plan in the 80 s to get rid of this stuff. so you now know they have had warning after warning congressman Burton saying this, I have had you in my hearings year after year asking you why, you want just get it out. (Atlanta Journal-Constitution -- Opinion)
Bioniche Reaches Special Protocol Assessment Agreement with U.S. FDA for Phase III Comparative Bladder Cancer Trial Sep 10, 2007
"This is a major milestone for the Company," said Cindy Benning, Vice-President of Operations, Quality and Regulatory Affairs of Bioniche Life Sciences Inc. "It indicates agreement by the FDA on the design of the study, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). A SPA gives a clear pathway to registration of Urocidin(TM) when the... (Canada Newswire)
GSA/HHS/FDA Dedicate New Engineering and Physics Laboratory in White Oak, Maryland Jun 15, 2007
The complex is scheduled to replace outdated existing fragmented facilities and will support FDA's Center for Drug Evaluation and Research (CDER), Center for Biological Evaluation and Research (CBER), Office of Regulatory Affairs (ORA) and Office of the Commissioner (OC) in addition to CDRH. FDA's current operations are scattered among 48 leased buildings throughout suburban Maryland. "GSA has enjoyed a close working relationship with FDA in the design and construction of this beautiful campus,"... (PR Newswire)
MaxCyte Organizes Stem Cell Session at BIO 2007 May 4, 2007
The MaxCyte system has an FDA Master File in place at CBER. Madhusudan Peshwa, Ph. D. Madhusudan V. Peshwa, Ph. (PR Newswire)
Boeing Operations Contribute $1.5 Billion Annually to Alabama Economy Oct 19, 2006
"As the largest aerospace company in the state, we are committed to the continued success of our customers, to the economic health of the state and to the overall quality of life in the communities where we live and work." The Center for Business and Economic Research (CBER), University of Alabama, Tuscaloosa, conducted the economic impact study on behalf of Boeing. Two years ago, CBER conducted a similar study for Boeing using 2003 data ... In operation since 1930, CBER is a major repository... (PR Newswire)
MaxCyte to Present at the 2006 BIO InvestorForum 2006 Oct 6, 2006
The MaxCyte system has an FDA Master File in place at CBER. For more information, visit. This press release may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. (PR Newswire)
LCT Reports Positive Meetings with FDA and MedSafe - Preparing for Cell Therapy Trials Feb 16, 2006
NeurotrophinCell: Representatives from LCT attended the pre-IND meeting with members of the National Institutes of Health (NIH) and reviewers from the Centre for Biologics Evaluation and Research (CBER), the group within the FDA responsible for the evaluation of biologics, including cell and gene therapies ... "We are grateful to the CBER team for their constructive comments and assistance in defining the most appropriate strategy for the NeurotrophinCell product, and we look forward to further... (PR Newswire)
