Three of the US FDA’s former leaders believe the agency is coming through COVID with its reputation intact. They still support making the agency independent of the broader Health & Human Services Department, but the urgency may be gone.

New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.

New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.

Three former commissioners believe FDA has come through the Trump administration relatively unscathed when compared to the reputational damage suffered by other government agencies. Will the Biden team agree?

Three former commissioners believe FDA has come through the Trump Administration relatively unscathed when compared to the reputational damage suffered by other government agencies. Will the Biden team agree?

There may be significant savings from eliminating wasteful packaging for high cost specialty drugs. The US FDA, however, is urging policy makers not to overlook the importance of patient safety in packaging issues.