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The complex is scheduled to replace outdated existing fragmented facilities and will support FDA's Center for Drug Evaluation and Research (CDER), Center for Biological Evaluation and Research (CBER),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)
