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Xcel Pharmaceuticals’ promotional materials for two migraine products omit risk information, make misleading comparative claims about safety and include unsubstantiated efficacy and indication claims, according to a letter from the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC).
The latest FDA draft guidelines on electronic submissions are likely to cause problems with firms submitting promotional material to the agency's Division of Drug Marketing, Advertising and Communications (DDMAC), the Biotechnology Industry Organization (BIO) told FDA in comments submitted late last month.