march 28, 2006 combination products: preparing for the journey march 28, 2006 pamela j. weagraff...
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March 28, 2006
Combination Products: Preparing for the Journey
March 28, 2006
Pamela J. WeagraffPrincipal Consultant
March 28, 2006
Combination Products –Combination Products –Preparing for the JourneyPreparing for the Journey
Consider and understand the law, know the regulations, make use of available resources - why is obvious to understand how your product will be regulated but what about . . .
When: in earliest phase of product development as part of establishing Regulatory strategy
Where and Who: Office of Combination Products - Mark Kramer, Director, and staff, of Center Jurisdictional Offices
What and How: Office of Combination Product’s web site, http://www.fda.gov/oc/combination
March 28, 2006
Preparing for the Journey – When?Preparing for the Journey – When?
First Phase of Product Development - Regulatory Strategy: assignment to a center with primary jurisdiction, or a lead center, is based on a determination of the “primary mode of action” (PMOA) of the combination product; develop . . .
A brief description of the product and its major components, intended use of the product, (clinical/therapeutic claims, including patient population)
An explanation of the product’s modes of action (how the product works); which mode of action is primary and attributable to device, drug or biologic
Consider need for formal or informal request for designation
March 28, 2006
Preparing for the Journey – When?Preparing for the Journey – When?
Informal or Formal Request for Designation (RFD): consider . . .
Known FDA experience with similar products, established precedents – suggests informal RFD
Mitigation of business risk or lack of similar products – suggests formal RFD
March 28, 2006
Preparing for the Journey – Preparing for the Journey – Where and Who?Where and Who?
Establish a relationship with the Office of Combination Products Staff:
Assignment of combination products – to Product Assignment Officer or Director
Regulatory identity of a product as a drug, device, biological product, tissue (HCT/P) or combination product – to Product Classification Officer or Director
Premarketing or post-marketing issues, including requests for facilitation or guidance – to either the Associate Director or the Senior Scientific Advisor
General policy or regulatory issues – to Director or Associate Director
March 28, 2006
Establish a relationship: if you are reasonably certain of designation, questions can be directed to Center jurisdictional offices
CBER: Sheryl Lard-Whiteford, Ph.D., 301-827-0379 CDRH: Eugene Berk, 240-276-0104 CDER: Warren Rumble, 301-443-5581
Preparing for the Journey – Preparing for the Journey – Where and Who?Where and Who?
March 28, 2006
Apply the OC Resources – Informal RFD
Contact either OCP or Center Jurisdictional Office
Present information developed as part of Regulatory Strategy: Brief description of the product / major components,
intended use, (clinical/therapeutic claims, including patient population)
Explanation of modes of action (MOA) (how the product works); which MOA is primary and attributable to device, drug or biologic
Request feedback on center assignment
Preparing for the Journey – Preparing for the Journey – What and How?What and How?
March 28, 2006
Apply the OC Resources – Formal RFD
Determine proceeding directly to RFD or submitting Pre-RFD
Contact OCP Director Discuss plan for Pre-RFD and RFD or proceeding directly to
RFD, provide Regulatory Strategy information Request feedback on plan
Develop Pre-RFD or RFD according to OCP Guidance: “How to Write a Request for Designation”, August 2005, contact Leigh Hayes, OCP, 301-427-1934
Preparing for the Journey – Preparing for the Journey – What and How?What and How?
March 28, 2006
Pre-RFD or RFD:
Follow the guidance document; contact Leigh Hayes, OCP, 301-427-1934, with any questions
Logistics: Electronic submissions accepted OCP review for completeness = 5 days If complete per regulation / guidance, distributed to
qualified individuals in Centers for review OCP RFD review = 60 days
Preparing for the Journey – Preparing for the Journey – What and How?What and How?
10> quintiles.com/quintilesconsulting
We’re off and assigned . . . We’re off and assigned . . .
Now what?
March 28, 2006
What good manufacturing practice regulations apply to combination products?
How are adverse events reported for combination products?
How will user fees for our combination product be applied?
What kind of safety and effectiveness information will be needed to support approval of our combination product?
How can master files can be used in the submission of information relevant to our combination product?
Ask Questions, All of Them!Ask Questions, All of Them!
March 28, 2006
Include OCP staff in meetings with designated Center personnel for Pre-IND or Pre-IDE meetings, cc on submission cover letter
Keep OCP staff apprised of project status and request assistance in event of disputes, informal or formal
Become VERY familiar with the OCP web site
Work the Relationship with OCPWork the Relationship with OCP
13> quintiles.com/quintilesconsulting
““Chance favors the prepared mind.”Chance favors the prepared mind.”
-- Louis Pasteur-- Louis Pasteur
Thank you!
Pamela J. Weagraff, MBA, RACPrincipal Consultant, Medical Device Development
Quintiles ConsultingTel: 508-528-1745
E-Mail: [email protected]