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CDER plant inspections up slightly in FY ''02, but drug advertising letters down 2/3.

Publication: Warning Letter Bulletin
Publication Date: 16-JUN-03 		Format: Online - approximately 817 words
Delivery: Immediate Online Access

Article Excerpt
Dear Reader,

As many had expected, the number of drug advertising letters, both warning and untitled that FDA issued in fiscal 2002, dropped by about two thirds from fiscal 2001, but pharmaceutical manufacturing inspections were higher during the fiscal year, which ended Sept. 30.

According to a chart the Center for Drugs released May 12 as part of its "CDER 2002 Report to the Nation: Improving Public Health Through Human Drugs," the Center's Division of Drug Marketing, Advertising and Communications (DDMAC) issued 37 regulatory "action letters"--which comprise both warning and untitled letters--versus 105 in fiscal 2001.

The likely reason for the decline is the change in policy in March 2002 that required all warning and untitled letters to be cleared...

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