FDA addresses product review glitch, raises prospect of bar codes
This article was originally published in Clinica
The US FDA says it will get tough on inappropriate use of "incomplete letters" by review staff to avoid failing to complete a review within the first review cycle, FDA deputy commissioner Lester Crawford said at last week's AdvaMed annual meeting. "We are very aware of the technique," Dr Crawford said. "FDA rarely says 'no'; they just say 'not now'," he said.
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