President's Corner

BIO Needs Your Feedback on Effective FDA – Sponsor Communication During Drug Development

Enhance scientific breakthroughs by letting BIO know your communication practices with the FDA during drug development.

In a letter written directly to BayBio, Jim Greenwood, president and CEO at BIO, requested assistance in capturing information about your interactions with FDA during the various stages of drug development prior to submitting an NDA/BLA. So, for the first time, we will be conducting an annual survey seeking information about your knowledge and experience in working with FDA. To take our short survey, please click here.

In an increasingly competitive and fiscally constrained environment, it is more important than ever that all stakeholders work together to promote effective research and development of innovative medicines. To that end, we have developed this survey in an effort to gain insight from the biomedical community that we can utilize to more effectively engage with FDA during the next round of PDUFA technical discussions on topics relevant to drug development. Specifically, 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 FDA’s existing communication practices and to help identify best practices for communicating with sponsors, which will further inform BIO’s advocacy relating to the development of future FDA standard operating procedures and guidance for industry and staff. 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.

To take this survey, please click here.

More than one employee from your company may take this survey, so please forward to 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.