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We Need Your Input: BIO Survey on Effective FDA-Sponsor Communication

March 4, 2015
BIO is surveying members and non-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.

Why is it important for you to share your feedback? 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.

In this BIO BuzzCenter video, Alnylam’s Dr. John Maraganore explains why this input is critical for guiding our conversations with the FDA.

An initial review of survey responses found that most drug sponsors are not using a special protocol assessment as they do not have any evidence that using it improves their changes of successful approval. While this early analysis revealed that FDA-sponsor interactions vary widely, overall drug sponsors indicated that more meetings seemed to speed up the pace of regulatory review. [For more details, please see Reviewing the Reviewers: FDA Divisions Get Mixed Results in BIO Survey in Pink Sheet (subscription)]

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. Participants of these survey initiatives will receive a periodic analysis of results.

To take our short survey and provide valuable feedback, please click here.