title: Balancing modern medical benefits and risks.
abstract: The changing landscape of medical benefits and risks creates new challenges for all stakeholders in health care. We offer examples of different medical interventions to help illustrate the complexity and diversity of considerations that define the trade-offs between benefits and risks for each patient. As more information becomes available at all stages of a product's life cycle, the Food and Drug Administration (FDA) needs to play a central role as an authoritative voice in communicating drugs' benefits and risks and must have the resources to perform the functions necessary to keep pace with this accelerating rate of change.
authors.affiliation: Johnson and Johnson Corporate Office, New Brunswick, New Jersey, USA. pjuhn9@corus.jnj.com
authors.forename: Peter
authors.initials: P
authors.lastname: Juhn
authors.forename: Audrey
authors.initials: A
authors.lastname: Phillips
authors.forename: Kathy
authors.initials: K
authors.lastname: Buto
mesh_terms: D003695:Delivery of Health Care / Q000379:methods*; D006801:Humans; D011785:Quality Assurance, Health Care / Q000379:methods; D018570:Risk Assessment / Q000379:methods; D012308:Risk Management / Q000379:methods*