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Refusal to Deal Under FDA Imposed Risk Evaluation and Mitigation Strategies (REMS): Economic Considerations

BY | April 29, 2014

This article is part of a Chronicle. See more from this Chronicle Robert Maness, Brian Segers, Apr 29, 2014 The Federal Trade Commission, as part of its ongoing enforcement of…

This article is part of a Chronicle. See more from this Chronicle

Robert Maness, Brian Segers, Apr 29, 2014

The Federal Trade Commission, as part of its ongoing enforcement of perceived anticompetitive abuse of the regulatory and legal structure in the pharmaceutical industry, has turned its gaze to branded pharmaceutical firms’ refusal to sell samples of restricted distribution products to firms seeking approval to market generic versions.

The types of restricted distribution arrangements

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