Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
FDA's Advisory Cmte. Meeting On Bladder Pain Syndrome May Signal Policy Changes
The Bone, Reproductive and Urologic Drugs Advisory Committee will consider endpoints, clinical trial designs and other issues related to development in the disease.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Genmab/AbbVie’s Tepkinly, for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Singapore To Require GMP Evidence On Chemical Drug Manufacturers
Singapore is taking steps to align good manufacturing practice requirements for chemical and biologic drug substance manufacturers and has rolled out a one-year transition plan for compliance.