BIO is surveying members on their interactions with the FDA during the various stages of drug development prior to submitting an NDA/BLA. The survey can be accessed here.
In an increasingly competitive and fiscally-constrained environment, it is more important than ever for all stakeholders to work together to promote effective R&D for innovative medicines.
This initial survey is designed to assist in the implementation of the Prescription Drug User Fee Act (PDUFA V) program on Enhancing Communication during drug development. Your feedback will be used to better understand and measure the FDA’s existing communication practices and help identify best practices for communicating with sponsors.
We are also seeking volunteers to participate in a more detailed survey that will enable us to examine interactions associated with drug development during specific phases of development, specific pathways, and disease areas. There will be an opportunity to sign up for that initiative at the end of this survey.
Participants of these survey initiatives will receive a periodic analysis of results.
More than one employee from your company may take this survey, so please share with your colleagues. This survey should only take 20-30 minutes to complete. We encourage coordinated responses to this survey, and for your convenience, a printable version of this survey can be found here.
To take our short survey and provide valuable feedback, please click here.