US FDA Doesn't Support Creating Ultra-Orphan Designation
Executive Summary
Agency is already approving drugs for diseases with much smaller patient populations than the traditional rare disease, officials note.
You may also be interested in...
Orphan Drug Policy Changes To Be Considered Under US FDA's FY 2019 Budget Proposal
Proposed $20m funding boost for rare disease development includes review of orphan incentives, including how to potentially stimulate development in ultra-orphan diseases.
Opioid, NME, And Generic Drugs Changes Plotted In US FDA's 2018 Policy Roadmap
‘Better informed patients,’ ‘drug competition,’ ‘biosimilar innovation’ – as well as nutrition and tobacco goals will be achieved through guidances, promotional plans and other items FDA will develop over the next year.
Opioid, NME, And Generic Drugs Changes Plotted In US FDA's 2018 Policy Roadmap
‘Better informed patients,’ ‘drug competition,’ ‘biosimilar innovation’ – as well as nutrition and tobacco goals will be achieved through guidances, promotional plans and other items FDA will develop over the next year.