Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

The US FDA has navigated one round of layoff notices, but more cuts could be coming. Here are three potential scenarios.

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In new draft guidance, the US FDA recommends sponsors carefully weigh the circumstances for requiring tissue biopsies for clinical trial subjects and emphasizes the need to limit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