Senate vote looms on user fee legislation

The Senate could begin voting today on vital user fee legislation for both the medical device and drug industries, Bloomberg reports. Fees for device companies are set to more than double to $609 million, the article notes, with the money set to help fuel the safety and efficacy reviews regulators conduct before a product is approved for the market. The legislation is also supposed to mandate more post-marketing studies and launch a way to electronically track devices. But the industry beat back efforts to prevent devices of low- to medium-risk from gaining clearance if a related device got slapped with a recall over safety reasons. Story

 

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