Either an IND or an IDE will be sufficient for companion diagnostic studies, a CDRH diagnostics official clarified last week. That is among the issues that will be addressed in an upcoming co-development draft guidance.
Companion diagnostic developers can use either an investigational device exemption or investigational new drug application as a means to study the assay for FDA approval, a top diagnostics official at CDRH clarified last week.
Industry groups commenting on the agency’s companion diagnostics draft guidance, released in July, have expressed concern that the wording of...
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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
