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FDA Dings Imaging Agent for Lack of Training Program

By Catherine Shaffer


Monday, March 21, 2011
The FDA issued a complete response letter to Eli Lilly and Co. and its wholly owned subsidiary, Avid Radiopharmaceuticals Inc., for its new drug application for Amyvid (florbetapir F 18 injection), an imaging agent to detect beta amyloid plaque in the brain. The FDA requested that Lilly provide a reader training program for marketing of the product to ensure accuracy and consistency in interpreting scans made with Amyvid.

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