Makena Vs. Avastin: No Contest When It Came To Withdrawal Process Duration
Executive Summary
Approximately 41 months passed from the initial advisory committee meeting in October 2019 on Makena’s potential withdrawal to the 5 April 2023 final decision by FDA's commissioner and chief scientist - more than double the length of the same interval in the accelerated approval withdrawal proceeding involving the breast cancer claim for Genentech's Avastin.
You may also be interested in...
Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures
Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.
Preterm Birth Patients Sought By US FDA As Meeting On Treatment Development Looms
With the only FDA-approved treatment off the market, the FDA is looking for ideas for development of new preterm birth treatments.
NASH Accelerated Approval: US FDA Remains Confident In Pathway For Liver Disease
A two-day workshop on potential biomarkers in NASH provided a forum for US FDA officials to offer implicit reassurance to drug developers: the agency stands behind its guidance on Accelerated Approval for the liver disease, despite the rejection of the first application seeking to use that approach.