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  • Legal and Regulatory Commercial Battles

    Thank you. The topic today is the off-label use of medical products. Dr. Scarpace had mentioned that considering how much off-label drug prescribing actually really occurs, what’s the real value of a label, right? The point is, the real value of an FDA approved label is that it provides another layer of regulatory and legal hurdles that the innovator company will use when they try to keep the generic company from launching their product. That’s how it’s used.