Brand/Generic Battles Over REMS Raise Constitutional Questions For FDA
ANDA sponsors may increasingly face a new roadblock to FDA approval: a Risk Evaluation and Mitigation Strategy (REMS) that restricts access to samples of the brand name product.
ANDA sponsors may increasingly face a new roadblock to FDA approval: a Risk Evaluation and Mitigation Strategy (REMS) that restricts access to samples of the brand name product.