SURVEY ON FDA’S REVIEW PROCESS FOR COMPANION DIAGNOSTICS
The
Combination Products Coalition (“CPC”) is conducting anonymous on-line surveys to gather data on manufacturers’ experiences with the review process for combination products and companion diagnostics. The objective is to help identify areas where there may be problems with, e.g., interCenter or Center-sponsor, communications so that industry and FDA can figure out ways to improve reviews. We plan to share our results from this survey with FDA and, potentially, with Congress and the broader public to advocate for process improvements.
The surveys ask about your company’s interactions with FDA to identify problems that may have had a significant effect on product review. The questions are multiple choice, although some include additional space for comments or specific details you would like to share. Also, there is a spot to provide your contact information if you would like to identify yourself or be contacted to discuss issues further.
Contact information will remain confidential and will not be shared with FDA or other individuals beyond the CPC survey administrators without your express permission.
We would like to have one response per applicable survey (combination product, companion diagnostic, or both) from each company or independent business unit so that information is not duplicated. Therefore, we ask that you designate an individual at your company/unit to collect information from, and complete a single survey for, the company/unit. We estimate that it will take no longer than 15-30 minutes to complete the survey.
Click "Next" to proceed with the Companion Diagnostic Survey.
The Combination Product Survey is available at:
http://www.surveygizmo.com/s3/1558128/867c9fffe187
We thank you in advance for your participation. We believe the results will be tremedously useful in improving the review process and bringing safe, effective, and innovative products to patients more quickly.
If you have questions about the surveys or the CPC, please feel free to contact James Boiani at
JBoiani@ebglaw.com or 202.861.1891.
