Warning Letters are a fact of life for the pharmaceutical industry and it can be difficult to avoid them. Not only are warning letters issued by FDA for cGMP deficiencies, letters can also be initiated by marketing or advertising blunders, including the misuse of social media and product websites.
Last week, Eli Lilly received an FDA Warning Letter after the agency’s routine monitoring and surveillance program spotted an image of a colored brain on the website for Amyvid, a diagnostic PET tracer used by healthcare professionals when evaluating Alzheimer’s Disease and other causes of cognitive decline. According to FDA, the brain classifies as misbranding because Amyvid’s product labeling states that images must be displayed and reviewed in black and white. Read more »