New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.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

CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.

Updated guidance on its authority to mandate postmarketing studies affirms that a new power to impose requirements to look for diminished efficacy reaches beyond the opioid drug class.