More bad news for the FDA and the public: "The FDA said a manufacturing plant owned by Ranbaxy Laboratories Ltd. falsified data and test results in approved and pending drug applications." Deborah Autor, the director of the FDA's Office of Compliance, says "most of the falsified data involves required tests to prove drugs are stable over a certain time period" (article here). However, the FDA "is not seeking a recall, because regulators do not believe the drugs pose a health risk," the Washington Post adds. "There is no concern about the safety or efficacy of Ranbaxy's drugs on the US market," Autor said.
How would she know?
Thursday, February 26, 2009
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