FDA User Fee Reauthorization Charges Along With Senate Passage
This article was originally published in The Gray Sheet
FDA user fee and reform bill sails through Senate on 96-1 vote. House plans to take up its similar legislation this week.
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Legislative leaders say they remain on track to send FDA user fee reauthorization and reform legislation for the president’s signature by the end of June following House passage of bill.
The Senate-approved Food and Drug Administration Safety and Innovation Act includes dozens of sections related to devices.
The Senate user fee reauthorization and FDA reform bill, formally introduced May 15, includes several new provisions, including a moratorium on FDA issuing final guidance on mobile medical apps. The bill should see action on the Senate floor this week.