Generics and Biosimilars Catch the FDA’s Eye

In his National Law Journal article, "Generics and Biosimilars Catch the FDA’s Eye," Zuckerman Spaeder LLP partner Andrew N. Goldfarb says that the Food and Drug Administration’s (FDA) regulation of drugs in 2014 reflected the agency’s constant effort to balance a range of interests and pressures to ensure the safety and effectiveness of drugs marketed in the United States. Mr. Goldfarb goes on to analyze several specific FDA issues that garnered attention in 2014 and that will remain relevant in 2015, including standards for establishing biosimilars, the FDA’s increased overseas activity, generic drug labeling, approval mechanisms for risk evaluation and mitigation, social media communications, drug compounding, and Hatch-Waxman Amendments.

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Katie Munroe
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