Combination Product Process
Developments
MassMEDIC Symposium
March 15, 2017
Waltham, MA (via teleconference)
John Barlow Weiner. Esq.
Associate Director for Policy
Office of Combination Products
US Food and Drug Administration
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Topics
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Premarket data
Intercenter consult process developments
Process tips for sponsors
Combination Products Council
General observations and take-aways
www.fda.gov
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Premarket Submissions
www.fda.gov
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Premarket submissions data cont’d
Of the 350 combination product premarket
submissions under BLA, NDA, PMA or 510(k)
received in FY15*:
• CBER Lead: 39
• CDER Lead: 185
• CDRH Lead: 126
www.fda.gov
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Intercenter Consults
www.fda.gov
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Consult data cont’d
Of the 1130 intercenter consultation requests:
• CBER sent 74 (46 to CDRH and 28 to CDER)
• CDRH sent 302 (300 to CDER and 2 to CBER)
• CDER sent 754 (747 to CDRH and 7 to CBER)
www.fda.gov
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Intercenter Consult Assessment
• October 2015 – Report on Intercenter Consult Process identified
several issues with existing process:
1. Differences in review timelines, review policies/practices, and
application types
2. Separate tracking systems
3. Uncertainty regarding communication channels between centers
• March 2016 – Launch lean management mapping for ICCR process
1. Capabilities Assessment
2. Current-State ICCR Process
3. Future-State ICCR Process
www.fda.gov
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Assessment Outcome
Combination product council mandate to
“modernize the inter-center consultation process”
• Pilot launched August, 2016
• Periodic analysis of consult process data,
focused audits, staff feedback, and real-time
adjustments
• Projected completion and implementation 2017
www.fda.gov
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Pilot approach
Key aspects/improvements
• Defined Timeline Goals
• Improved forms, access to databases, and tracking
• Tiered approach and clarified roles
• Pre-established, updated contact points
• Outreach and training to staff on combination products and
consult process improvements
• Centralized process resources for staff in Centers and OCP
www.fda.gov
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Tips for Sponsors
• Clearly identify submissions for “combination products”
• Make sure that you submit them to the correct Center
– if you have questions about jurisdiction, contact OCP prior to submission
• Provide a “road map” in the submission to help staff find
relevant constituent part information
• Request representatives from the non-Lead Center and/or OCP
for meetings when you think warranted
• Make sure that the feedback you receive is from the Agency
(i.e., reflects input of all appropriate review team members)
• Provide feedback - Let us know what is and isn’t working well
www.fda.gov
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Combination Products Council
• Senior-level forum to address combination product policy
• Chaired by the Deputy Commissioner for Medical Products
and Tobacco or his/her designee, and includes the Center
Directors for CBER, CDER, and CDRH and the Office Director
for OCP, or their designees
• Charter available at: Combination Products Council
charter:
https://www.fda.gov/downloads/AboutFDA/ReportsManua
lsForms/StaffManualGuides/UCM528113.pdf
www.fda.gov
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CPC cont’d
• The Council members identify regulatory and
scientific policy issues to address
• In addition to combination products, the Council
can address other products intended for combined
use with one another and classification of medical
products
• The Council can help resolve disagreements among
Centers, the Office of Combination Products (OCP),
and/or sponsors (the Council does not meet
directly with sponsors)
www.fda.gov
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General observations/take-aways
• Focus on efficiency, consistency and
coordination
• Commitment to a risk-based approach
• Commitment to speaking with one voice
• Desire to hear from you and work together
• Look to OCP as a resource
www.fda.gov
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Contacting OCP
John. [email protected]
[email protected]
301-796-8930 (Tel)
301-847-8619 (Fax)
www.fda.gov/CombinationProducts/default.htm
www.fda.gov
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www.fda.gov