2020
DOI: 10.1002/pds.5073
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FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes

Abstract: Purpose Prior literature reviews have identified gaps in understanding of how postmarketing safety labeling changes and related FDA communications impact key clinical and behavioral outcomes. We conducted a review of newly published studies on this topic to determine what new evidence exists and to identify which gaps may still remain. We believe that this information can support FDA as it develops and implements future risk communication approaches. Methods We searched PubMed and Embase for studies published … Show more

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Cited by 3 publications
(9 citation statements)
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“…The formal study of the impact of regulatory interventions is a relatively new area of study and its methods and data sources are evolving. A number of systematic reviews have described the methods and data sources, including real‐world data sources, that have been used in these studies 11–16 . Although these systematic reviews used various inclusion criteria and covered variable time periods, their findings were generally consistent across many of the factors they examined.…”
Section: Systematic Reviews Of Studies Of Measuring the Impact Of Regulatory Interventionsmentioning
confidence: 99%
See 4 more Smart Citations
“…The formal study of the impact of regulatory interventions is a relatively new area of study and its methods and data sources are evolving. A number of systematic reviews have described the methods and data sources, including real‐world data sources, that have been used in these studies 11–16 . Although these systematic reviews used various inclusion criteria and covered variable time periods, their findings were generally consistent across many of the factors they examined.…”
Section: Systematic Reviews Of Studies Of Measuring the Impact Of Regulatory Interventionsmentioning
confidence: 99%
“…Drug risk communications, such as Direct Healthcare Professional Communications, Boxed Warnings (sometimes called Black Box Warnings), and Public Health Advisories, were the most commonly studied regulatory interventions 15,16 ; other interventions, such as education programs, 14 pack‐size restrictions, 15 and pregnancy prevention programs, 14 were less frequently studied. Regulatory interventions related to a small number of products accounted for a large number of studies.…”
Section: Systematic Reviews Of Studies Of Measuring the Impact Of Regulatory Interventionsmentioning
confidence: 99%
See 3 more Smart Citations