New BIO Survey on Effective FDA – Sponsor Communication During Drug Development

Summary: 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 Read More