BIO Submits Comments on FDA Draft Guidance for Safety Labeling Changes

BIO views this Draft Guidance as an important step in further implementing a process for safety labeling changes that ensures patients and their physicians have access to timely, relevant, and science-based prescribing information to make informed decisions about their health. It is also important to BIO members that decisions to change safety labeling be based upon reliable information; that the process be cooperative and involve the application holder to the extent that is feasible; and that the labeling change and the process of adopting the change be in the best interest of public health.