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Pressure Mounts On FDA After Public Release Of Surveillance Documents

Multiple investigations and lawsuits have opened in response to the matter, with more potentially to come. Some worry the intensifying issue has serious implications for the quality of the device center’s output.

FDA and CDRH officials are facing escalating pressure following the accidental public release of thousands of emails and documents captured by agency surveillance of CDRH scientists who complained to Congress and others about the device review process.

Multiple investigations and lawsuits have opened in response to the matter, with more potentially to come. Some FDA watchers, both from industry and consumer advocacy groups, worry the intensifying issue...

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