New Scheduling Schedule: DEA Meets 90-Day Deadline For UCB’s Briviact
Executive Summary
UCB’s Briviact (brivaracetam) is the first product cleared under a new accelerated process for new molecular entities subject to the Controlled Substances Act scheduling process. Will the focus shift to FDA’s timelines next?
You may also be interested in...
Zydus Sets Sight On First US Generic Of UCB’s Briviact
Zydus Cadila has scooped another material ANDA approval from the FDA, with the green light for its generic version of UCB’s Briviact to treat partial-onset seizures.
Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.