Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Cempra's Solithromycin On Track To Enter Generic, But Resistant, CABP Market
FDA schedules November advisory committee for Cempra's first-in-class antibiotic for community-acquired bacterial pneumonia.
As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.