The Combination Products Coalition (“CPC”) is conducting this survey to assess the need for guidance about combination product issues. The CPC conducted a similar survey in 2008, and the results of this survey will be compared to the previous survey to assess progress that’s been made in recent years. The results also will be submitted to and discussed with FDA and will be reported to relevant professional and trade organizations.

Before completing this survey, it may be useful to review the FDA’s guidance and rule-making activities. Information is available at: http://www.fda.gov/CombinationProducts/default.htm.

INSTRUCTIONS

This survey should be completed by a staff member at your organization who is responsible for combination products. Please submit one only survey per company. It may be effective to involve multiple staff members in order to offer comprehensive views.

Please answer all questions. This survey should require less than 30 minutes to complete. Additionally, several questions provide opportunities for text comments. You are encouraged to use these comment areas to explain or elaborate on your answers.

All responses will be analyzed in aggregate and will be kept confidential. Any individual or organization information also will be kept confidential and will not be associated with any responses.

Thank you for your time and attention to this survey. We believe that the results will be tremendously useful to FDA and will ultimately benefit industry as well.

Question Title

* 1. What is the primary product focus of your organization?

Question Title

* 2. Please estimate your organization’s annual U.S. sales of its combination products:

Question Title

* 3. How experienced is your organization with developing and commercializing combination products?

Question Title

* 4. How many combination products has your organization developed and brought to market?

Question Title

* 5. Please indicate the development stage of your organization’s combination product. If your organization has more than one combination product, please indicate the stage of the combination product that is farthest along in the development/commercialization process.

Question Title

* 6. What type(s) of combination product(s) is your organization currently developing or marketing? (check all that apply):

Question Title

* 7. (Optional) Please provide the name and address of the corporate entity that is responding to the survey:

Question Title

* 8. (Optional) Please provide the following information for each person who helped to complete this survey for your organization: Name, Title, and Years of Experience with Combination Products

Question Title

* 9. Did you / your company complete this survey when it was offered in 2008?

Question Title

* 10. How satisfied is your organization with existing guidance on combination products, including FDA and non-FDA sources of guidance (e.g., publications from organizations other than FDA, trade or industry groups, consultants, legal counsel, etc):

 
 33% of survey complete.

T