Transcript Slide 1

Pamela J. Weagraff
Principal Consultant
Combination Products:
Preparing for the Journey
March 28, 2006 March 28, 2006
Combination Products –
Preparing 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?
 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?
 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 –
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
Preparing for the Journey –
Where and Who?
 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
March 28, 2006
Preparing for the Journey –
What and How?
 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
March 28, 2006
Preparing for the Journey –
What and How?
 Apply the OC Resources – Formal RFD
 Determine proceeding directly to RFD or submitting PreRFD
 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
March 28, 2006
Preparing for the Journey –
What and How?
 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
March 28, 2006
We’re off and assigned . . .
Now what?
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Ask Questions, All of Them!
 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?
March 28, 2006
Work the Relationship with OCP
 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
March 28, 2006
“Chance favors the prepared mind.”
-- Louis Pasteur
Thank you!
Pamela J. Weagraff, MBA, RAC
Principal Consultant, Medical Device Development
Quintiles Consulting
Tel: 508-528-1745
E-Mail: [email protected]
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