US FDA Role In Biomanufacturing Initiative Largely Packages Ongoing Works
The White House ‘Biotechnology’ initiative is very broadly focused, with non-health sectors receiving the bulk of the attention. The US FDA’s role is small – but it could further boost attention to efforts to encourage adoption of advanced manufacturing.
You may also be interested in...
Agency drafts guidance on how to apply requirements for chemistry, manufacturing and controls, and for good manufacturing practices, to bespoke antisense nucleotides.
Soon-to-be-released white papers will FRAME how FDA plans assess products manufactured with advanced technologies as part of an initiative to reduce uncertainty for sponsors.
The US Medicare Payment Advisory Commission is continuing its work on proposals to overhaul federal payment for physician administered drugs. That is an ominous message for the biopharma industry as it reels from passage of dramatic pricing legislation earlier this year.