The public will have a chance to discuss the tentative deal US FDA struck with industry to collect almost $1bn over five years in the next iteration of the device user-fee program at a statutorily-mandated meeting scheduled for Nov. 2.
Industry and public representatives alike can sign up to participate in an open meeting early next month at US FDA headquarters to talk about the fourth device user-fee deal recently struck with the agency.
FDA and industry trade groups announced that a draft MDUFA IV agreement was reached in August. The agreement includes some...
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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
