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Top FDA Compliance Official Notes 'Revival' Of Data Integrity Fraud

 
• By Joanne S. Eglovitch

A top FDA compliance official warns the generic drug industry of a “revival” of data integrity fraud as a number of brand-name drugs go off patent and companies rush to be the first to file.

A top FDA compliance official said that data integrity problems are not going away any time soon as many brand-name drugs are now going off patent and the pressure to be the first to file intensifies with an “enormous” amount of money at stake, harking back to the days of the generic drug scandal.

Thomas Cosgrove, director of the Office of Manufacturing Quality in the Office of Compliance in FDA's Center for Drug Evaluation...

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