Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression
US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
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US FDA rebuffs PhRMA’s request to clarify how the six statutory factors are weighed and to explain how it decides what a REMS should look like. All six factors are considered together to inform agency’s decision-making on the need for a Risk Evaluation and Mitigation Strategy, according to final version of guidance first issued in 2016.
The latest drug development news and highlights from our US FDA Performance Tracker.
Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.