This message was posted by a user wishing to remain anonymous
Does anyone have experience with dispute resolution and Office of Orphan Products Development?
Any of the resources I can find (guidance, MAPPs, SOPPs, law blog articles, PDUFA performance goals, etc) are specific to dispute resolution within review divisions.
Specifically I'd like to know:
- Is there a specific ombudsman for OOPD Dispute Resolution?
- Is there precedent for Orphan Designation Denial Dispute Resolution?
- Are there statistics or any probability of success with this process?
- Is there a known deciding official for dispute resolution above the OOPD director level?
Many Thanks!