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Today, the British Medicines and Healthcare products Regulatory Agency (MHRA) lifted their October 5, 2004 suspension of Chiron’s license to manufacture influenza vaccine.
FDA has been working closely with MHRA, including during inspections, as the agency evaluates Chiron’s progress in correcting their manufacturing problems. FDA considers MHRA's action today an extremely important milestone in Chiron's efforts to supply influenza vaccine for the U.S. market for the coming flu season, but work remains. FDA and MHRA will continue to closely monitor Chiron’s progress as manufacturing proceeds. When all critical stages of manufacturing are in full swing, and needed corrective actions can be fully evaluated, FDA plans to conduct a comprehensive inspection of Chiron's Liverpool facility to assure that Chiron can produce a safe and effective vaccine.
FDA is committed to assuring that all vaccines available in the U.S. are safe and effective.
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