FDA BRIEF: Week of October 3, 2016
precisionFDA’s Next Challenge? Conduct an App-a-Thon!
By:
Zivana Tezak, Ph.D., Associate Director, Science and Technology, CDRH
Elaine Johanson, precisionFDA Project Manager, Deputy Director Office of Health informatics
precisionFDA
- Online research portal
- FDA scientists + Silicon Valley minds
- Part of President Obama’s Precision Medicine Initiative (PMI)
Tasks
- Advance the use of next generation sequencing (NGS)
- Map entire human genome; data, analytics, and sequencing tools
- Open source cloud-based space for data, ideas, and methodologies sharing
- > 1,600 participants
“App-a-Thon”: Closes Oct 28, 2016
- Add NGS software apps for simulations, benchmarking, data integration, mapping portions of the genome, or identifying genetic variants
- Add to the precisionFDA app library
- FDA provides framework and materials, storage, and compute capacity
- Results to be highlighted by FDA Commissioner at World Precision Medicine Congress on Nov. 14, 2016 in Washington D.C
Our 20th Patient-Focused Drug Development meeting: Enhancing the patient’s voice in FDA’s approach to drug review and development
By:
Theresa M. Mullin, Ph.D., Director, Office of Strategic Programs, CDER
Patient Focused Drug Development (PFDD) program launched as part of PDUFA V
- PFDD meetings helps FDA strengthen understanding of targeted disease areas and hear directly from patients, families, and caregivers about symptoms that matter most to them
- 20th PFDD public meeting with organ transplant patients occurred Sept 27th
- All meetings chronicled in Voice of the Patient reports
- Plan to hold 4 more PFDD meetings in 2017
Externally-led Patient-Focused Drug Development Meetings
- To expand PFDD benefits, FDA welcomes patient-focused meetings organized by the patient groups themselves
- Interested patient groups can submit a letter of intent
Externally-led Patient-Focused Drug Development Meetings
2016-2017 CDER Drug Safety Priorities: Initiatives and Innovation
CDER’s programs to ensure safety of drug products and evolving drug safety enterprise
Miletones and broad picture of FDA’s multidisciplinary collaborations and partnership
Drug Safety Oversight Across the Product Lifecycle
Advancing Drug Safety Science
- JumpStart – Enhancing Pre-Market Drug Review with Digital Tools
- Postmarketing Safety Surveillance and Oversight
- Improving Drug Safety through Research
- Advancing Drug Safety Science through Public-Private Partnerships
Improving Operations and Management in Support of Drug Safety
- The 2015 GAO Report: A Call To Improve Data on Safety Issues
- Opioid Addiction and Abuse: Addressing a National Crisis
- Safe Use Initiative
- Working to Ensure Drug Product Quality
- Compounded Drugs and Drug Supply Chain Security
Communicating Drug Safety: A Global Public Interface
- Expert Responses to Public Queries
- Social Media and Online Tools
- Drug Safety Communications
- Safety Labeling Changes
- Risk Communications Research
FY 2017 User Fees for Priority Disease Review Vouchers
Rare Pediatric Disease Priority Review Voucher
- Fee rate and payment procedures Federal Register Notice
Tropical Disease Priority Review Voucher
- Fee rate Federal Register Notice
OPEN- Consumer Representative Positions on FDA Advisory Committee
Role:
- Represent consumer perspective on issues and actions before Advisory Committee
- Serve as liaison between Committee and interested consumers, associations, coalitions, and consumer organizations
- Facilitate dialogue with Committees on scientific issues that affect consumers.. FDA is currently recruiting to fill
Consumer Representative positions.
OPEN- Nominations for Voting Members for CDRH Patient Engagement Advisory Committee
Role:
- Improve communication of benefits, risks, clinical outcomes
- Increase integration of patient perspective in regulatory process
- Identify new approaches, unforeseen risks, unintended consequences resulting from FDA policy
CDRH Patient Engagement member