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Expert Analysis

Inside FDA Regulation Of Antibody Drug Conjugates

Law360, New York (July 17, 2015, 11:31 AM EDT) -- Antibody drug conjugates (ADCs) are therapeutic products that include a monoclonal antibody conjugated to a drug. ADCs are thus a combination of two separate classes of products regulated by the United States Food & Drug Administration: a biologic and a drug. Understanding how the FDA regulates ADCs and how regulatory data exclusivity will likely be awarded for different types of ADCs is of critical importance to life science companies that are developing these new types of innovative and targeted biopharmaceuticals....

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