Despite concerns from the brand industry, no major changes were made to provisions in the US Food and Drug Administration’s user fee reauthorization bill allowing generic drug sponsors more inactive ingredient information as it breezed to the House floor.
House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval
Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.
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