Articles Tagged with ''FDA''

FDA Updates 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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FDA Inspections Down, Recalls Up in 2006

Domestic and foreign FDA inspections of biologic and drug manufacturing facilities declined for fiscal 2006, from 4,513 in 2005 to 4,237, according to a recent report from the Office of Regulatory Affairs.

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