Indications, Labeling, and Outcomes Assessment for Drugs Aimed at Improving Functional Status in Older Persons: A Conversation Between Aging Researchers and FDA Regulators
Bhasin S, Espeland M, Evans W, Ferrucci L, Fried L, Gill T, Pahor M, Studenski S, Guralnik J, Nayfield S, Romashkin S, Perlstein R, Burke L, Parks M. Indications, Labeling, and Outcomes Assessment for Drugs Aimed at Improving Functional Status in Older Persons: A Conversation Between Aging Researchers and FDA Regulators. The Journals Of Gerontology Series A 2009, 64A: 487-491. PMID: 19270182, PMCID: PMC2657175, DOI: 10.1093/gerona/gln042.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsActivities of Daily LivingAgedAged, 80 and overAgingCognition DisordersDose-Response Relationship, DrugFemaleFrail ElderlyGeriatric AssessmentHumansInterdisciplinary CommunicationMaleOutcome Assessment, Health CarePharmaceutical PreparationsPhysical FitnessPractice Guidelines as TopicResearchRisk AssessmentSensitivity and SpecificityUnited StatesUnited States Food and Drug Administration