CSL Could Be Barred From U.S. For Vaccine Probe Failures
This article was originally published in PharmAsia News
Executive Summary
Australia's CSL, maker of a popular influenza vaccine, is under fire by U.S. FDA and Australia's Therapeutic Goods Administration for failing to investigate problems with its major-selling drug last year
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Australia's CSL, maker of a popular influenza vaccine, is under fire by U.S. FDA and Australia's Therapeutic Goods Administration for failing to investigate problems with its major-selling drug last year. FDA went so far as to threaten to revoke CSL's license to operate in the United States if it fails to get to the bottom of vaccine-manufacturing deficiencies that led to some of its shots causing adverse events in children. TGA added it had noted five audits showing problems with the company's response. A TGA spokeswoman said the Aussie agency's problems with CSL were similar to those found by FDA. (Click here for more) "CSL's U.S. Licence At Risk Over Flu Vaccine Failings" - The Australian (7/23/11) |