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U.S. Department of Health and Human Services

Drugs

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Questions and Answers for the CDER Science and Research Needs Report

     
  1. This document appears to be a comprehensive list of scientific needs, does CDER have particular needs that are a high priority?
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1: If I have ongoing efforts that address needs identified in the report, how can I convey that information?
Please submit all comments to the docket.  Comments will be captured, documented, and passed on to the appropriate stakeholders within CDER.  The comments received from the FR notice will be communicated directly to those at CDER who are involved in related ongoing science and research efforts and initiatives and will create opportunities to exchange knowledge and foster collaboration.

 
2: How does CDER’s Science and Research Needs Report relate to FDA’s Critical Path Initiative?
The FDA Critical Path Report and Opportunities List were published in 2004 and 2006. These reports focused on the scientific challenges underlying medical product development and served as a catalyst for CDER to launch an effort to identify specific areas that would benefit from additional regulatory science efforts. There are various ongoing Critical Path projects that support needs identified in CDER’s Science and Research Needs Report.
 
3: How does this report relate to the FDA’s Regulatory Science initiative?
The FDA has recently released, “Advancing Regulatory Science for Public Health”, which incorporates the Critical Path objectives into a broad framework for advancing regulatory science. This effort is directly linked to FDA’s Regulatory Science Initiative.  The CDER Science and Research Needs report articulates regulatory scientific needs from the perspective of the CDER community.  
 
4: This document appears to be a comprehensive list of scientific needs, does CDER have particular needs that are a high priority?
Developing a list of science needs is an essential first step to formulating priorities which will guide development of a science and research agenda. CDER is currently engaged in a number of efforts to identify priorities among the science needs that could be addressed through targeted research projects. These priorities will be assessed within the broad framework of FDA’s overall regulatory science objectives.  It is hoped that comments from the FR notice will identify additional external efforts that could address identified gaps.
 
5: How does this report relate to the FDA and NIH collaborative partnership?
The NIH-FDA collaborative partnership is focused on translational science and regulatory science by proposing to develop new tools, standards and approaches needed to properly assess the safety, effectiveness and quality of products currently in development or already on the market. This report may inform the development of projects and priorities for this new effort.
 
6: If a particular scientific area is not mentioned in the report, does that mean CDER is not interested in addressing it?
No. There are many scientific areas that may not have been mentioned in this document that are still important to CDER. For example, the report is not intended to address the clear and compelling need to maintain a robust scientific readiness to respond rapidly to regulatory crises, such as contaminated heparin, nor does the document focus on scientific infrastructure needs being addressed through other initiatives (e.g., informatics infrastructure).
 
7:  There seem to be a lot of needs articulated; is CDER addressing any of them?
Yes. There are a number of ongoing science and research efforts directed towards these needs, some of which are mentioned in this document.  However, we would like to enhance our ability to address these needs.  FDA has already partnered with academics, industry, other government agencies and nonprofits on many initiatives and we would like to expand these collaborations.