Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

Sara Brenner has been a key figure in the FDA’s diagnostics team, but her choice as acting FDA commissioner likely has more to do with her background with advanced technology and comfort level with the tech-focused side of the Trump transition team.

Sara Brenner has been a key figure in the FDA’s diagnostics team, but her choice as acting FDA commissioner likely has more to do with her background with advanced technology and comfort level with the tech-focused side of the Trump transition team.

In new draft guidance, the US FDA recommends sponsors carefully weigh the circumstances for requiring tissue biopsies for clinical trial subjects and emphasizes the need to limit them in pediatric studies.

Kennedy’s nomination for HHS secretary already is drawing concerns, which could mean a more conventional pick emerges, but industry should prepare for Kennedy to control the US Health and Human Services Department for at least some time.