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May 3, 2016Published Article

Antitrust Woes: What is the Cost of FDA Compliance?

Intellectual Property Magazine

In 2007, in response to the withdrawal of drugs such as Rezulin and Vioxx1 due to safety concerns, the US Congress enacted the Food and Drug Administration Amendments Act (FDAAA) of 2007. The FDAAA granted the Food and Drug Administration (FDA) authority to require a risk evaluation and mitigation strategy (REMS) from a sponsor of a new drug application (NDA) to ensure that the benefits of certain drugs outweighed its risks.2Although the FDAAA does not provide precise criteria for when the FDA can insist on a REMS, the FDA only requires REMS for drugs with high-risk profiles.3

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