FDA: Shining A New Light On Benefit-Risk Analysis

Law360, New York (April 19, 2012, 1:42 PM EDT) -- In furtherance of the Transparency Initiative launched in 2009, the U.S. Food and Drug Administration (FDA) published its first-ever guidance document on benefit-risk analysis for medical devices. This groundbreaking document is the first to attempt an explanation of the sometimes nebulous benefit-risk analysis that forms the cornerstone of FDA approval.

The self-proclaimed purpose of the guidelines, which will take effect on May 1, 2012, is to “improve the predictability, consistency and transparency of the premarket review process.”

Unfortunately, the guidance does not address the most commonly...
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