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James S. Cohen

James S. Cohen

McDermott Will & Emery


Latest Publications

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Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

5/7/2013 - Biosimilars FDA Fees Meet and Confer Sponsors

Federal Court Vacates Conviction for Truthful Off-Label Promotion of FDA-Approved Drug

In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit...more

12/11/2012 - FDA Off-Label Promotion Pharmaceutical

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