MDS customers to revalidate tests |
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Thu, 11 Jan 2007 15:10
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NEW YORK (AFX) - MDS Inc., a product and service supplier to drug-research companies, said U.S. regulators ordered some MDS clients to revalidate test results from MDS facilities used to support regulatory applications.The review comes after Food and Drug Administration inspections revealed serious concerns about drug testing at MDS's St. Laurent and Blainville, Quebec, plants from January 2000 to December 2004, the Toronto company said.The data was used in regulatory applications for potentially hundreds of drugs. The FDA said it won't remove any drugs from the market, but the precautionary review could slow the approval of some drugs awaiting U.S. clearance.The FDA said companies who used the facilities in that period will have to either repeat the studies, reanalyze original study samples at a different facility or independently audit the original results, MDS said in a press release late Wednesday.MDS was not immediately available to say the potential costs or to name any of the companies involved.FDA officials have identified all 217 generic drugs that either have won or are seeking federal approval and that included MDS Pharma studies in their applications.For brand-name drugs, the FDA isn't as sure which companies relied on testing done by MDS Pharma Services. As a result, it is notifying all brand-name drug makers that submitted the more than 900 applications received since 2000 to comb through their files to find out.Copyright 2006 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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