US Funding Law Could Speed Approval Of Drugs And Biologics Manufactured In Advanced Ways
Executive Summary
FY 2023 appropriations language requires HHS Secretary to designate advanced manufacturing technologies for expedited review, and to follow up with advice and meetings that could help move things along.
You may also be interested in...
How US FDA Must Designate Manufacturing Platforms To Help Speed Approvals
Initial product approvals will kick off a process that an FY23 spending bill provision establishes for the pharmaceutical industry to build on prior knowledge from manufacturing platform technologies. But the FDA can only designate platforms that really will expedite the development and review of new drugs and biologics.
Advanced Manufacturing Centers Of Excellence Measure Finally Clears US Congress
Nearly four years after introduction and a half-dozen legislative attempts, proposal to establish academic centers of excellence – hoped to help usher in a renaissance in US pharmaceutical manufacturing – secures passage in omnibus spending bill. New law also supports emerging technologies, building on the FDA’s Critical Path Initiative.
Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate
Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages.