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Coalition Survey to Guide FDA on Combination Products


Posted by mddiadmin on November 1, 2007

Medtech companies involved in developing combination products have a golden opportunity to offer input about future policy development priorities for FDA's Office of Combination Products (OCP), thanks to an online survey launched earlier this month. Sponsored by the Combination Products Coalition (CPC; Washington, DC), the “FDA Guidance Survey” is intended to assess the needs of medtech companies for regulatory guidance on combination product issues.

 
Thompson
 


According to CPC general counsel Bradley Merrill Thompson, a member in the healthcare and life sciences practice of Epstein Becker & Green PC (Washington, DC), the survey results will be useful to FDA and members of industry in reviewing OCP's guidance and rule-making activities. “The goal of the survey is to take the pulse of companies in the combination product area, and to discover what their most-pressing FDA-related issues are,” says Thompson.

When the survey results have been compiled, CPC representatives expect to meet with FDA in order to present and discuss the findings with the agency. “OCP is going through a leadership change, so now is an opportune time for industry to offer input about the regulation of combination products,” says Thompson.

The Combination Products Coalition (www.combinationproducts.com) includes a number of leading companies in the drug, device, and biologics industries. The coalition works to improve the regulatory environment for combination products by developing and advocating policy positions on regulatory issues affecting combination products.

“The unique cross-industry membership of the CPC enables diverse thinking that leads to sound policies,” says Thompson. “This diversity distinguishes the CPC from other industry organizations.”

The CPC survey offers participants a list of 17 distinct regulatory topics, and asks them to select the five areas in which they believe guidance for combination products is needed most. Topics included in the list are the following.

  • Adverse event reporting
  • Advertising and promotional issues
  • Clinical studies
  • Combination product definition
  • Cross-labeled combination products
  • Good manufacturing practices (GMPs)
  • Labeling
  • Postapproval inspections
  • Postapproval modification issues
  • Preapproval inspections
  • Preclinical research
  • Premarket approval submissions
  • Primary mode of action
  • Recall requirements
  • Resolving disputes
  • Request for designation (RFD) and product jurisdiction
  • User fees

The survey also asks participants to rank the type of guidance they consider most useful for each of their priority areas. Types of guidance listed include question-and-answer or frequently-asked-questions documents, workshops or public meetings, written guidance documents, case studies and examples, or other formats.

CPC's instructions for the online survey indicate that it should be completed only by professionals working with combination products within their organizations, and that only one survey should be completed for each organization. However the coalition advises participants to collaborate with combination product colleagues in their companies, so that the survey responses provide a comprehensive view of the companies' activities. Respondents are encouraged to elaborate on their answers in comment boxes provided within the survey.

According to CPC, completing the survey takes approximately 20–25 minutes. All information submitted in the survey will be kept strictly confidential. Individual or organizational information is not identifiable unless the participant chooses to submit optional demographic information.

CPC has indicated that it will be keeping the online survey open for new participants until the end of December 2007, after which the results will be tabulated for presentation to FDA. The complete online survey can be accessed via http://research.zarca.com/clients/RAPS/survey.aspx?sid=47&lang=0.

© 2007 Canon Communications LLC

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