MDUFA IV Stakeholder Meeting Minutes
FDA BRIEF: Week of April 25 2016
STAKEHOLDERS : Duke University, National Center for Health Research, Alliance for Aging Research, Epilepsy Foundation, National Coalition for Cancer Survivorship, National Health Council, American College of Cardiology, American Academy of Neurosurgery, FasterCures, Society for Women’s Health Research, Pew Charitable Trusts, National Organization for Rare Disorders, Research!America, Avalere Health
- FDA discussed the current status of proposals
-Cost of additional enhancements to program as identified by Industry
-Industry vs FDA areas of interest and priority
-Additional discussions needed to close gap in priority assessments
- FDA presentation: Inter-center consultation review process for combination products
-History and Challenges
-Recommendations: Increased collaboration, review consistency, improved IT access, expedited data access, standardized processes and guidances