Peer-influenced content. Sources you trust. No registration required. This is HCN.

ReachMD“Tentative Approval”: Understanding the FDA Ruling on Once-Nightly Sodium Oxybate

Sleep medicine specialists, psychiatrists, neurologists, ENTs, and PCPs should be able to define the FDA drug approval regulations surrounding “tentative approval” status after completing this 0.25-credit, 15-minute educational CME activity. They should also be able to describe the clinical outcomes from the pivotal trials of once-nightly sodium oxybate demonstrating its safety and efficacy and identify the “non-drug” issues that are the cause of the FDA’s delay in approving the once-nightly medication for insomnia.

The Healthcare Communications Network is owned and operated by IQVIA Inc.

Click below to leave this site and continue to IQVIA’s Privacy Choices form