title: New FDA regulation to improve safety reporting in clinical trials.
authors.affiliation: Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Rachel Behrman
authors.initials: RB
authors.lastname: Sherman
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
authors.forename: Janet
authors.initials: J
authors.lastname: Norden
authors.forename: Cheryl
authors.initials: C
authors.lastname: Grandinetti
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Temple
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D033161:Government Regulation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration