FDA to reevaluate ReGen knee repair device

The AP (3/19, Perrone) reported that ReGen Biologics, the medical device maker “at the center of a highly controversial Food and Drug Administration approval, is pushing back against the agency’s plan to reevaluate” its Menaflex knee repair implant. The company’s “implant spent more than three contentious years under review at the FDA before gaining approval in 2008.” But “when newly appointed Obama administration officials re-examined the approval last year, they concluded that FDA’s decision was influenced by intense lobbying by lawmakers from Regen’s home state of New Jersey.”

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