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FDA Notifies Pharmaceutical Companies to Confirm or Repeat
Analytic Studies Used in the Approval of a Number of Drug Products
As a precaution, the Food and Drug Administration (FDA) is notifying certain pharmaceutical companies to recommend that they reevaluate pharmacokinetic studies that were conducted for them by MDS Pharma Services (MDS Pharma) at its St. Laurent (Montreal) and Blainville, Quebec, Canada sites from 2000 through 2004. MDS Pharma is a contract company that performs these pharmacokinetic testing services for a number of pharmaceutical companies. A pharmacokinetic study is used to measure the level of drug in a patient’s blood. The results of the study can be part of the basis for the approval of a drug by the Agency.
FDA is taking this action as a result of FDA inspections of two MDS Pharma Canadian facilities that raised questions about the validity and accuracy of test results from studies conducted by MDS Pharma from 2000 through 2004. FDA has worked with MDS Pharma to address these issues concerning its test results and is now following up directly with all pharmaceutical companies with marketed drugs or pending drug applications that may be affected by these testing issues. FDA has identified all of the approved generic drugs and generic drugs pending approval that are affected by these MDS Pharma studies and is notifying these companies of FDA's recommendation for reevaluation of these studies. For brand-name drugs, FDA is notifying all companies that submitted applications during the affected time period to identify any studies conducted on their behalf by MDS Pharma at its St. Laurent (Montreal) and Blainville, Quebec, Canada sites.
FDA will be working with the affected companies to ensure, where necessary, that they validate their pharmacokinetic data through audits, new analyses or repeating their tests within a reasonable period of time.
FDA is taking this action as a precautionary measure to ensure that data submitted to the Agency and used in making approval decisions is of the highest quality. FDA’s routine adverse event surveillance monitoring program has not detected any signals or any evidence that any of the drugs involved pose a safety risk or that there has been any impact on efficacy. FDA does not have any evidence that there are problems with the quality, purity, or potency of the affected drug products.
- Letter to Sponsor of Pending Abbreviated New Drug Application(s) (ANDAs) [PDF] [HTML]
- Letter to Sponsor of an Approved Abbreviated New Drug Application(s) (ANDAs) [PDF] [HTML]
- Letter to Sponsor of an Approved New Drug Application(s) (NDAs) [PDF] [HTML] (posted 2/1/2007)
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Date created: January 10, 2007, updated February 1, 2007 |
