User Fee Discussions Include Funding Parts Of FDA Regulatory Science Plan
Commissioner Margaret Hamburg’s plans to improve regulatory science at FDA could benefit from application user fees, based on PDUFA negotiations.
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Orphan Designation Removals To Be Revealed By FDA
List will include whether a designation was lost, but not why, FDA says in final rule clarifying and updated 1992 orphan drug regulations.
Targeted Therapies On FDA’s Orphan Designation Radar
As personalized medicine continues to grow, FDA is watching to see if there is a rise in orphan designations for products targeting a “smaller slice” of a common disease.
PDUFA V: Sentinel, Regulatory Science Upgrades Could Gain User Fee Funding
FDA’s Sentinel Initiative appears to be gaining support through the Prescription Drug User Fee Act, although industry is not interested in blindly pumping user fee revenue into the project.