US FDA’s Comirnaty Review By The Numbers
A timeline of the review and development of the first COVID-19 vaccine to win BLA approval.
You may also be interested in...
Agency recommendation for randomized controlled trials in ultra-rare pediatric disease is unworkable for various reasons, say advocates and sponsors who seek use of the accelerated approval pathway based on changes in heparan sulfate levels.
Clinical Trial Diversity Planning Requires Prevalence-Based Enrollment Goals, Metrics For Gauging Success
Academic and industry experts caution against relying on historical enrollment numbers when setting new targets for under-represented populations and tout real-time monitoring dashboards, as well as a role for data monitoring committees, in assessing whether targets are being met in ongoing studies.
Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.