BIO is re-launching a streamlined version of our FDA communications survey to gauge the effectiveness of FDA-sponsor interactions during drug development. This brief survey asks about topics such as communications channels, special designations, and clinical holds. The survey is pivotal for BIO’s ongoing efforts to ensure the FDA review process is working as well as it can. In the past, a similar survey has been critical in our continuous efforts to work with FDA on best practices and to reauthorize PDUFA. The results will be incorporated into BIO’s advocacy agenda to ensure a science-driven, innovative, well-resourced FDA. To participate, simply click here to go to the survey, or use the QR code below. After you access the survey, you will receive a personalized link via email. If you don’t see the email, please check your spam folder. Once you receive the link, you can begin the survey, which takes about 5 minutes to complete. Data will be analyzed in aggregate and not on level of an individual company or program to maintain anonymity. You will be asked basic information about your company and programs and provide vital feedback on your experience interacting with FDA. The survey’s clinical program journals are the heart of the survey. Please take a few minutes to answer these questions for each notable interaction with FDA during development.
Participating companies will receive exclusive access to survey data during a webinar in 2024. Again, all data and feedback will be anonymized. If you have questions about the survey you may reach out to fdasurveysupport@bio.org. Thank you in advance for your participation in this important effort!