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Medical Devices

Senate passes FDA user fee reauthorization

Senate passes FDA user fee reauthorization

The bill, which now awaits the president's approval, has received broad support from medical device and pharmaceutical groups as a means to add more certainty and efficiency to the product review process.

Cardinal Health profit declines as generic drug prices deflate

The Dublin, Ohio-based pharmaceutical and medical products distributor saw its pharmaceutical segment profit drop 7% to $505 million as companies along the pharmaceutical supply chain have taken a financial hit resulting from the increasing scrutiny surrounding surging drug prices.

House passes bipartisan FDA user fee bill

House passes bipartisan FDA user fee bill

The House of Representatives passed bipartisan legislation Wednesday that reauthorizes the FDA's ability to collect user fees from drug and device makers, as policymakers look to avoid thousands of layoffs if the current agreement expires.

FDA user-fee extension breezes through Senate committee

FDA user-fee extension breezes through Senate committee

The act, which calls for more than $400 million in additional user fees to be collected from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, looks to expedite new drug approvals. The committee added amendments aimed at increasing competition.

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