title: Secondary pharmacology data to assess potential off-target activity of new drugs: a regulatory perspective.
authors: Division of Cardiovascular and Renal Products, US Food and Drug Administration.
authors: Thomas
authors: T
authors: Papoian
authors: Division of Hematology Oncology Toxicology, US Food and Drug Administration.
authors: Haw-Jyh
authors: HJ
authors: Chiu
authors: Division of Psychiatry Products, US Food and Drug Administration.
authors: Ikram
authors: I
authors: Elayan
authors: Division of Cardiovascular and Renal Products, US Food and Drug Administration.
authors: Gowraganahalli
authors: G
authors: Jagadeesh
authors: Division of Psychiatry Products, US Food and Drug Administration.
authors: Imran
authors: I
authors: Khan
authors: Division of Medical Imaging Products, US Food and Drug Administration.
authors: Adebayo A
authors: AA
authors: Laniyonu
authors: Division of Nonprescription Drug Products, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
authors: Cindy Xinguang
authors: CX
authors: Li
authors: Division of Cardiovascular and Renal Products, US Food and Drug Administration.
authors: Muriel
authors: M
authors: Saulnier
authors: Division of Hematology Oncology Toxicology, US Food and Drug Administration.
authors: Natalie
authors: N
authors: Simpson
authors: Division of Cardiovascular and Renal Products, US Food and Drug Administration.
authors: Baichun
authors: B
authors: Yang
mesh_terms: D000818:Animals; D003362:Cost-Benefit Analysis; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D056687:Off-Label Use; D010601:Pharmacology, Clinical / Q000639:trends*; D013329:Structure-Activity Relationship