Articles Tagged with ''FDA''

FDA Releases 2007 Investigations Operations Manual

The FDA added noncompliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM).

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Lawmakers Request PDUFA Timing Information From FDA

Two leading House members sent a letter to FDA Commissioner Andrew von Eschenbach asking him when he would have to alert agency employees about possible layoffs if the Prescription Drug User Fee Act (PDUFA) is not reauthorized.

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