In this week’s roundup: Watching for a restart to FDA user fee talks and Califf’s confirmation. EU steps on standards, companion diagnostics, health technology assessments, and notified bodies. FDA progresses on quality system harmonization and device shortage notifications, and forges a new imaging office. More from the US, Canada, UK, and Singapore.
What we’re watching for:
User fee talks stalled. We are looking for signs of life in FDA-industry MDUFA V talks after learning that the two sides have not met for negotiations since before Thanksgiving and have no meeting scheduled. Meanwhile, there is talk that committees in Congress might start looking to schedule hearings on FDA user fee reauthorizations sometime in February. Read more here: Device User Fee Talks Stalled as a Deadline Approaches, Market Pathways, January 10, 2022.
Califf confirmation? We are also on the lookout for the Senate Health, Education, Labor, Pensions (HELP) Committee’s vote on Robert Califf’s confirmation as the next FDA commissioner, expected January 13. If the vote is positive, as expected, that will clear the way for a full Senate vote in the coming weeks or month.