FDA Orphan-Only Review Division Could Speed Access, Gottlieb Suggests
This article was originally published in The Pink Sheet Daily
As agency issues take center stage at a pharmacoeconomics meeting, American Enterprise Institute fellow recommends reorganizing review divisions to accelerate approval of orphan drugs.
You may also be interested in...
US FDA commissioner nominee might employ modular specialists to work with review divisions on issues related to gene therapies, molecularly-targeted drugs, adaptive clinical trial designs, or other complex issues.
Former US FDA, CMS official has been among those thought to be in the running for Trump's FDA commissioner nomination.
Pricing drugs differently by indication presents an opportunity to better align the cost of medicines to value in certain cases, but the regulatory, policy and administrative challenges are daunting. Experts debated the challenges and opportunities during the ISPOR annual meeting.