Why Phase III Still Matters
Executive Summary
Avycaz dosing for renally impaired patients was carefully considered based on sophisticated PK/PD analysis and Phase II data used to support its expedited limited use approval. Even so, the Phase III trials still uncovered a problem.
You may also be interested in...
Patient-Focused Meeting On Vitiligo Could Galvanize R&D As The First Drug Candidates In A Long Time Advance
US FDA meeting directs attention to the vitiligo patient experience as a small group of potential treatments, led by topical Janus kinase inhibitors, are at the Phase II hinge point.
Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021
With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.
Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval
Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.