Combination Product Updates - AWS
Combination Product Updates BIO Convention 2017 San Diego, CA Melissa Burns Senior Program Manager Office of Combination Products US Food and Drug Administration Pg1
Intercenter Consult Assessment • October 2015 – Report on Intercenter Consult Process identified several issues with existing process • March 2016 – Launch lean management mapping for ICCR process • Pilot process improvements 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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Intercenter Consult Pilot Approach • • • •
Defined Timeline Goals Improved forms, access to databases, and tracking Tiered approach and clarified roles Outreach and training to staff on combination products and consult process improvements • Centralized process resources and contact points for staff in Centers and OCP • Audits www.fda.gov
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Combination Products Council (CPC) • 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, Associate Commissioner for OSMP, and the Office Director for OCP, or their designees • Charter available at: https://www.fda.gov/downloads/AboutFDA/ReportsMan ualsForms/StaffManualGuides/UCM528113.pdf www.fda.gov
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Combination Product Submission Tips • Clearly identify submissions for combination products • 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 • Ask if you are unsure whether feedback you receive is from the Agency (i.e., reflects input of all review team members) • Make sure that you submit to the correct Center • Give us feedback - Let us know what is and isn’t working well www.fda.gov
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Other Combination Product Activities • Pre-RFD Process (Draft Guidance issued January 2017) • Combination Product CGMPs (Final Guidance issued January 2017) • Postmarket Safety Reporting for Combination Products (Final Rule published December 2016, Draft Guidance being developed) • Role of Human Factors Studies in Combination Product Design and Development (Draft Guidance issued January 2016) www.fda.gov
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Contacting OCP [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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Intercenter Consult Assessment • October 2015 – Report on Intercenter Consult Process identified several issues with existing process • March 2016 – Launch lean management mapping for ICCR process • Pilot process improvements 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
Pg2
Intercenter Consult Pilot Approach • • • •
Defined Timeline Goals Improved forms, access to databases, and tracking Tiered approach and clarified roles Outreach and training to staff on combination products and consult process improvements • Centralized process resources and contact points for staff in Centers and OCP • Audits www.fda.gov
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Combination Products Council (CPC) • 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, Associate Commissioner for OSMP, and the Office Director for OCP, or their designees • Charter available at: https://www.fda.gov/downloads/AboutFDA/ReportsMan ualsForms/StaffManualGuides/UCM528113.pdf www.fda.gov
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Combination Product Submission Tips • Clearly identify submissions for combination products • 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 • Ask if you are unsure whether feedback you receive is from the Agency (i.e., reflects input of all review team members) • Make sure that you submit to the correct Center • Give us feedback - Let us know what is and isn’t working well www.fda.gov
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Other Combination Product Activities • Pre-RFD Process (Draft Guidance issued January 2017) • Combination Product CGMPs (Final Guidance issued January 2017) • Postmarket Safety Reporting for Combination Products (Final Rule published December 2016, Draft Guidance being developed) • Role of Human Factors Studies in Combination Product Design and Development (Draft Guidance issued January 2016) www.fda.gov
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Contacting OCP [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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