Scott Gottlieb was sworn in as the 23rd commissioner of FDA May 11, and device industry groups are hoping he hits the ground running in advocating for quick passage in Congress of user-fee reauthorization and FDA reform legislation.
The bill includes the MDUFA IV agreement reached last summer to increase industry fees in return for enhanced performance and investments in the US FDA pre-market review process. It advanced through the Senate Health, Education, Labor and Pensions Committee on the same day Gottlieb was sworn in, and it has also made progress in the House
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