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The successful supplier will also be required to perform all necessary work and submit the required reports and applications needed to obtain Health Canada's Special Access Programme (SAP) approval as well as licensure approval in Canada from the Canadian Regulator (the Bureau of Biologics and Genetic Therapies Directorate, Health Canada).
Chiron Corporation (Nasdaq: CHIR) announced today that Health Canada's Bureau of Biologics and Radiopharmaceuticals (BBR) granted the company a license to market Menjugate(TM), a conjugate vaccine against disease caused by the bacterium Neisseria meningitidis serogroup C (MenC).
This section is responsible for developing a research programme in biotechnology as well as supporting a sister regulatory bureau, the Bureau of Biologics, with its safety and efficacy evaluations of novel drug products obtained through biotechnology.
Accordingly, Hemosol filed amendments to the original Investigational New Drug submission to include knee replacement surgery, and subsequently received regulatory clearance from the Bureau of Biologics of Health Canada.
During the meeting, held at the FDA's Bureau of Biologics in Rockville, Md.
Cohen joins NABI following more than 20 years' experience in regulatory affairs, including eight years with the NIH as chief, Blood and Blood Derivatives Section, four years at the FDA's Bureau of Biologics as director, Plasma Derivatives Branch, and 16 years as vice president, regulatory affairs, with Pasteur Merieux and Connaught.
Barker first served as Medical Officer at the Bureau of Biologics, Food and Drug Administration and Division of Biologics Standards, National Institute of Health, Bethesda, MD from 1962- 1978.
NASDAQ: IMMU) announced today that it has filed with the Bureau of Biologics and the Bureau of Radiation and Medical Devices of the Health Bureau Protectorate for approval to market in Canada ImmuRAID(TM)-CEA, the Company's colorectal cancer imaging agent.