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Regulatory Focus™ > News Articles > Making Sense of FDA’s Postmarket Surveillance Program

Making Sense of FDA’s Postmarket Surveillance Program

Posted 01 September 2009

Throughout the clinical development process, sponsors maintain a laser-like focus on getting to the finish line-receiving marketing approval from the US Food and Drug Administration (FDA) for a drug, biologic or medical device. But what happens next, when the product is launched and is now available to the public? That is when sponsors realize that the game really is only half over, and postmarket surveillance comes into play to monitor the newly approved product throughout its lifecycle.

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