FDA BRIEF: Week of Aug 1, 2016
Piloting an Improved Intercenter Consult Process
by:
Michael Rappel, Ph.D., Senior Science Advisor, CDER and Member, Lean Management Team
Rachel E. Sherman, M.D., M.P.H., Associate Deputy Commissioner
FDA’s efforts to improve review of combination product (combine drugs, devices, and/or biological products)
- Establishing Combination Product Council
- Process improvements through lean mapping
- Intercenter Consult Request (ICCR) being piloted
Important ICCR improvements:
- Establishing timelines for consults
- Streamline and Optimize interactions across centers
- Clear roles and responsibilities for Lead Center, Consulted Center(s), Office of Combination Products (OCP), and Combination Product Council
- User-friendly ICCR form t.
Continuous learning:
- Collect quantitative and qualitative data to evaluate success
- Refine ICCR process
- ICCR pilot comprised of three phases, phase 1 planned for two months
- Iterative approach to ensure robust process
Feedback appreciated: [email protected].
How do clinical holds impact drug development programs?
by: Larissa Lapteva, M.D., CDER
Do clinical holds impact drug development – especially potential treatments for rare diseases?
Q/A with Dr. Lapteva
Investigational Drug Application( IND): By companies/academia to test investigational drug effects
Clinical Hold: If FDA finds issues with safety or quality; hold will last until sponsor adequately addresses all issues
FDA’s research into clinical holds:
- Objective and informative assessment to identify and avoid common pitfalls
- Clinical holds not frequent; ~ 9% INDs
- Off Hold : >50% within 1 yr; . ~76% rare disease INDs vs. 40% for common disease
- Most common deficiencies: Quality issues, clinical, toxicology issues
- Similar issues for rare vs. common diseases
- Recommended Reg strategies: Read applicable guidances, Early FDA communication
- CDER engages in not-for-profit events (including conferences, meetings, symposia, webinars, and workshops) co-sponsored with organization(s)
- Provide relevant expertise and share a mutual interest and benefit in the subject matter
- May participate as a speaker
- The Medical Device User Fee Amendments (MDUFA) require payment of user fee for medical device applications
- Fees are lower compared to FY2016 fees
- “small business” (sales no more than $100 million/yr) eligible for reduction in fees
- guidance for “foreign business”
