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Human drugs.

Publication: Warning Letter Bulletin
Publication Date: 16-JUN-03 		Format: Online - approximately 1110 words
Delivery: Immediate Online Access

Article Excerpt
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Warner Chilcott, Rockaway, NJ, March 18 (NJ). From Oct. 7-18, 2002, New Jersey District investigators Erin McCaffery and Helen Ricalde visited the firm and determined several post-marketing adverse drug experience (PADE) reporting violations. The letter stated that Warner failed to review and submit to the FDA required PADE reports; specifically, there were 21 telephone log entries describing ADEs that were not reviewed or reported to FDA. The majority of the ADEs were for the company's Estrace tablets, Ovcon 35 and Estrace Cream. Further, the inspectors noted that nine telephone log entry reports were inadequate in that they were illegible or lacked sufficient text to identify the nature of the call in order to determine if a reportable ADE had occurred. C-H

Hoffmann-La Roche receives warning letter for patient-directed sales aid and video

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Hoffmann-La Roche, Nutley, NJ, May 29 (DDMAC).

FDA objected to Roche's dissemination of a promotional, patient-directed sales aid and video for its drug, Xeloda (capecitabine). The agency found that the video...

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