FDA BRIEF: Week of Aug 1, 2016

Voice

 

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 

Michael Rappel

Rachel Sherman

FDA’s efforts to improve review of combination product (combine drugs, devices, and/or biological products)

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: combinationproductICCRpilot@fda.hhs.gov.

READ


How do clinical holds impact drug development programs?

by: Larissa Lapteva, M.D., CDER

 

Larissa Lapteva, M.D.

 

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

READ


CDER

  • 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

READ


MDUFA.JPG

guidance.JPG

  • 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”

fees.JPG

READ

GUIDANCE


 

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