The US Food and Drug Administration’s label development process may benefit from an additional layer of insight beyond the sponsor and FDA staff who develop the material because confusing language can make prescription coverage decisions more challenging for payers or even lead to adverse coverage.
Key Takeaways
- Earlier label discussions during review could improve the understanding between ‘regulatory land’ and the kingdom of reimbursement, even within sponsors themselves.
The need for improved labeling review came up at a 31 January Bipartisan Policy Center event focused on how to...
