US FDA Commissioner Scott Gottlieb sat down with Medtech Insight and Pink Sheet reporters for an exclusive chat about his ongoing regulatory work and plans for the future.
Since taking over as FDA commissioner in May, Scott Gottlieb has moved forward at a ferocious pace in rolling out new major initiatives and advancing policy developments that will have significant impacts on product-makers and patients alike.
Gottlieb spoke Nov. 3 before National Press Club in Washington, D.C. (Also see "Five Takeaways From Commissioner Gottlieb's Talk...
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
