Slides (Updated 9/13/13)
Slides (Updated 9/13/13)
Slides (Updated 9/13/13)
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Overview of Activity:<br />
October 2012-September 20<strong>13</strong><br />
§ CDER/Office of Prescription Drug Promotion (OPDP):<br />
§ 1 Warning Letter<br />
§ 18 Untitled Letters<br />
§ 2 letters noted offending materials were picked up by FDA personnel at<br />
conferences<br />
§ CBER Advertising and Promotional Labeling Branch (APLB)<br />
§ 1 Untitled Letter<br />
§ OPDP oversees advertising/promotion of therapeutic biologics<br />
§ 2 of OPDP’s Untitled Letters were for BLAs<br />
§<br />
Compared to prior years, downward trend in letters, especially in warning letters<br />
2
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