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FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies by I. Glenn Cohen, Holly Fernandez Lynch (Hardcover, 2015)

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ISBN-13: 9780231171182, 978-0231171182. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. FDA in the Twenty-First Century.