CPC Conducts Survey on FDA’s Final Rule on Postmarket Safety Reporting for Combination Products

The Combination Products Coalition (“CPC”) is conducting a brief survey to assess industry readiness for implementation of FDA’s Final Rule on Postmarketing Safety Reporting for Combination Products (available here). We hope to use your responses to help advise FDA on reasonable expectations for how long it will take companies to come into compliance with the Final Rule as well as provide insight about potential hurdles, recognizing that FDA guidance on the Final Rule is still forthcoming.  All of your responses will be kept anonymous.

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 approximately 10 minutes to complete the survey.

Take the survey here: https://www.surveymonkey.com/r/MGGXK9D

Please Complete the Survey No Later Than February 2, 2018.

We thank you in advance for your participation. If you have any questions, please feel free to contact Priya Kaulich at PKaulich@ebglaw.com or 312.499.1433.