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Pharma Compliance Info FDA Faulted for Problems With Drug Tracking Pharmacovigilance

FDA Faulted for Problems With Drug Tracking

WASHINGTON Pharma Compliance Info FDA Faulted for Problems With Drug Tracking Pharmacovigilance
Federal investigators said Thursday that there were flaws in the way the Food and Drug Administration tracked drugs after they came to market, raising questions about the agency’s effectiveness as the country’s main drug overseer.
Once the agency approves a drug, it is required to monitor the drug’s safety as well as efforts by the company that makes it to study how the drug is doing in the marketplace, for example whether many patients are reporting problems while taking it. The investigators, from the Government Accountability Office, a nonpartisan investigative arm of Congress, looked at how the F.D.A. was doing with those tasks.
The answer was not very well.
“F.D.A.’s data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult,” the accountability office concluded in its report.

To read the article by Sabrina Tavernise

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